<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749109</url>
  </required_header>
  <id_info>
    <org_study_id>000295</org_study_id>
    <nct_id>NCT03749109</nct_id>
  </id_info>
  <brief_title>Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis</brief_title>
  <acronym>QLARITY</acronym>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial&#xD;
      investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions&#xD;
      assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep&#xD;
      infiltrating endometriosis, and/or adenomyosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2019</start_date>
  <completion_date type="Actual">July 18, 2021</completion_date>
  <primary_completion_date type="Actual">June 21, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.&#xD;
At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)</time_frame>
    <description>Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&amp;B) Scale at Cycle 4</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)</time_frame>
    <description>B&amp;B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs.&#xD;
In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E.&#xD;
The score can be between 0 and 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4</measure>
    <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
    <description>Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.&#xD;
Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:&#xD;
during the last menstrual cycle&#xD;
during the menstrual period of the last menstrual cycle&#xD;
during the non-menstrual period of the last menstrual cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4</measure>
    <time_frame>At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
    <description>EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.&#xD;
It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)</measure>
    <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
    <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)</measure>
    <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
    <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4</measure>
    <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4</measure>
    <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4</measure>
    <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4</measure>
    <time_frame>Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Hematocrit</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Platelets</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Leukocytes</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Albumin</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Bilirubin</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Calcium</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Chloride</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Cholesterol</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Creatinine</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Glucose</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Phosphate</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Potassium</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Sodium</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Protein</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Urate</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters</measure>
    <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by blood sample collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and Intensity of Adverse Events</measure>
    <time_frame>From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)</time_frame>
    <description>Assessed by and Adverse Event Log completed by the Investigator</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Quinagolide 1080 µg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vaginal ring containing matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quinagolide 1080 µg</intervention_name>
    <description>Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
    <arm_group_label>Quinagolide 1080 µg</arm_group_label>
    <other_name>FE 999051</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of&#xD;
             signing the informed consent&#xD;
&#xD;
          2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening&#xD;
&#xD;
          3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by&#xD;
             high-resolution MRI at screening&#xD;
&#xD;
          4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of&#xD;
             endometrium and presence of at least one ovary with no clinically significant&#xD;
             abnormalities at screening. Note that presence of uterine fibroids are not&#xD;
             exclusionary but presence of any submucosal fibroids or polyps are exclusionary&#xD;
&#xD;
          5. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for&#xD;
             contraception from the start of screening to the end-of-treatment. This is not&#xD;
             required if adequate contraception is achieved by vasectomy of the male sexual&#xD;
             partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as&#xD;
             ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse&#xD;
             with men requiring condom use)&#xD;
&#xD;
          6. Willing to avoid the use of vaginal douches or any other intravaginally administered&#xD;
             medications or devices (except for tampons) from randomization to the end of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening&#xD;
             visit.&#xD;
&#xD;
          2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists&#xD;
             within 6 months prior to the screening visit.&#xD;
&#xD;
          3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase&#xD;
             inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or&#xD;
             levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the&#xD;
             screening visit.&#xD;
&#xD;
          4. Use of hormonal contraceptives (including combined oral contraceptive pill,&#xD;
             transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the&#xD;
             screening visit.&#xD;
&#xD;
          5. Contraindications to MRI such as having internal/external metallic devices and/or&#xD;
             accessories (e.g. cardiac pacemakers and leg braces)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gyneacology Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Opsedaliera Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Roma La Sapienza</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Integrata Verona</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne PROMED</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Lekarski Specjalistyczny SONUS</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczny Gabinet Lekarski</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
  </location_countries>
  <removed_countries>
    <country>Spain</country>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <results_first_submitted>June 21, 2022</results_first_submitted>
  <results_first_submitted_qc>August 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2022</results_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrioma</keyword>
  <keyword>Adenomyosis</keyword>
  <keyword>Deep infiltrating endometriosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quinagolide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03749109/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03749109/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was performed in 6 investigational sites in 3 countries between Aug 2019 to Jul 2021.</recruitment_details>
      <pre_assignment_details>In total, 147 subjects were screened. Of these, 80 were screening failures and 67 were randomized and exposed to the investigational medicinal product (IMP): 35 to Quinagolide and 32 to Placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Quinagolide 1080 µg</title>
          <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Quinagolide 1080 µg</title>
          <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="67"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.9" spread="5.51"/>
                    <measurement group_id="B2" value="35.2" spread="5.96"/>
                    <measurement group_id="B3" value="36.1" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.91" spread="3.86"/>
                    <measurement group_id="B2" value="23.30" spread="4.15"/>
                    <measurement group_id="B3" value="23.62" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.&#xD;
At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.&#xD;
At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="4.34"/>
                    <measurement group_id="O2" value="-1.94" spread="4.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.41" spread="2.52"/>
                    <measurement group_id="O2" value="-0.94" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.10" spread="3.75"/>
                    <measurement group_id="O2" value="-3.43" spread="3.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.78</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>1.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.45</ci_lower_limit>
            <ci_upper_limit>13.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.29</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>3.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.89</ci_lower_limit>
            <ci_upper_limit>9.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.95</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.33</ci_lower_limit>
            <ci_upper_limit>10.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Percentage of changes in the size</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.64" spread="70.12"/>
                    <measurement group_id="O2" value="-6.83" spread="44.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.67" spread="15.22"/>
                    <measurement group_id="O2" value="5.81" spread="37.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.04" spread="32.31"/>
                    <measurement group_id="O2" value="-6.99" spread="25.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.65</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-6.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.80</ci_lower_limit>
            <ci_upper_limit>22.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.92</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.77</ci_lower_limit>
            <ci_upper_limit>20.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.74</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-5.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.94</ci_lower_limit>
            <ci_upper_limit>29.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Percentage of lesions</units>
          <param>Number</param>
          <units_analyzed>Lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Lesions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9"/>
                    <measurement group_id="O2" value="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Lesions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Lesions</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.95</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>2.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.39</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.14</ci_lower_limit>
            <ci_upper_limit>2.17</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0"/>
                    <measurement group_id="O2" value="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.60</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>2.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.21</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma - Disappearing Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE - Disappearing Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis - Disappearing Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma - New Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE - New Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis - New Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma - Disappearing Lesions</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Negative-binomial regression</method>
            <param_type>Rate Ratio</param_type>
            <param_value>2.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>8.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis - Disappearing Lesions</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.56</p_value>
            <method>Negative-binomial regression</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>5.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4</title>
        <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, and 45 subjects in the DIE group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4</title>
          <description>The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, and 45 subjects in the DIE group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="4.62"/>
                    <measurement group_id="O2" value="1.89" spread="4.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="1.81"/>
                    <measurement group_id="O2" value="-0.87" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.97</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.78</ci_lower_limit>
            <ci_upper_limit>13.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.74</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.63</ci_lower_limit>
            <ci_upper_limit>5.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4</title>
        <description>Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4</title>
          <description>Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.19" spread="8.70"/>
                    <measurement group_id="O2" value="4.06" spread="9.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.42</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>10.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.74</ci_lower_limit>
            <ci_upper_limit>35.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&amp;B) Scale at Cycle 4</title>
        <description>B&amp;B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs.&#xD;
In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E.&#xD;
The score can be between 0 and 15.</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&amp;B) Scale at Cycle 4</title>
          <description>B&amp;B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs.&#xD;
In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3.&#xD;
The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E.&#xD;
The score can be between 0 and 15.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.26"/>
                    <measurement group_id="O2" value="-2.1" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="2.16"/>
                    <measurement group_id="O2" value="-1.6" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="2.33"/>
                    <measurement group_id="O2" value="-1.9" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.10</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>2.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.67</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.02</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.64</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4</title>
        <description>Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.&#xD;
Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:&#xD;
during the last menstrual cycle&#xD;
during the menstrual period of the last menstrual cycle&#xD;
during the non-menstrual period of the last menstrual cycle</description>
        <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4</title>
          <description>Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.&#xD;
Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:&#xD;
during the last menstrual cycle&#xD;
during the menstrual period of the last menstrual cycle&#xD;
during the non-menstrual period of the last menstrual cycle</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.96"/>
                    <measurement group_id="O2" value="-0.7" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.17"/>
                    <measurement group_id="O2" value="-1.1" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.73"/>
                    <measurement group_id="O2" value="-1.1" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.11"/>
                    <measurement group_id="O2" value="-2.0" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.14"/>
                    <measurement group_id="O2" value="-0.7" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="2.20"/>
                    <measurement group_id="O2" value="-1.4" spread="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.65"/>
                    <measurement group_id="O2" value="-1.0" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.27"/>
                    <measurement group_id="O2" value="-2.1" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.84"/>
                    <measurement group_id="O2" value="-0.7" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="2.37"/>
                    <measurement group_id="O2" value="-0.9" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="2.34"/>
                    <measurement group_id="O2" value="-0.9" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.91"/>
                    <measurement group_id="O2" value="-1.9" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.73</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.02</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.54</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>1.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.46</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.86</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.49</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.99</ci_lower_limit>
            <ci_upper_limit>2.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.32</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.83</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.38</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.11</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>2.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.93</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.85</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.58</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.68</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4</title>
        <description>EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.&#xD;
It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.</description>
        <time_frame>At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4</title>
          <description>EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.&#xD;
It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.6" spread="90.49"/>
                    <measurement group_id="O2" value="-51.0" spread="71.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.6" spread="88.84"/>
                    <measurement group_id="O2" value="-94.0" spread="85.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.6" spread="91.14"/>
                    <measurement group_id="O2" value="-41.7" spread="86.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.8" spread="87.29"/>
                    <measurement group_id="O2" value="-85.7" spread="98.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.3" spread="102.92"/>
                    <measurement group_id="O2" value="-33.2" spread="52.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.9" spread="105.62"/>
                    <measurement group_id="O2" value="-79.4" spread="90.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.75</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-7.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-53.97</ci_lower_limit>
            <ci_upper_limit>39.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Endometrioma at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.42</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>17.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.41</ci_lower_limit>
            <ci_upper_limit>60.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.47</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-17.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.30</ci_lower_limit>
            <ci_upper_limit>30.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DIE at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.27</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>25.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.05</ci_lower_limit>
            <ci_upper_limit>72.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>-20.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-71.83</ci_lower_limit>
            <ci_upper_limit>29.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adenomyosis at cycle 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.93</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA adjusted for baseline lesion size.</method_desc>
            <param_type>Difference in LS mean</param_type>
            <param_value>2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.57</ci_lower_limit>
            <ci_upper_limit>54.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)</title>
        <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.</description>
        <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)</title>
          <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="10.54"/>
                    <measurement group_id="O2" value="32.6" spread="10.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" spread="2.92"/>
                    <measurement group_id="O2" value="26.9" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" spread="2.13"/>
                    <measurement group_id="O2" value="27.4" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="2.12"/>
                    <measurement group_id="O2" value="28.3" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" spread="3.27"/>
                    <measurement group_id="O2" value="26.9" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" spread="11.80"/>
                    <measurement group_id="O2" value="31.4" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="2.66"/>
                    <measurement group_id="O2" value="27.3" spread="2.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4" spread="1.98"/>
                    <measurement group_id="O2" value="27.7" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" spread="2.86"/>
                    <measurement group_id="O2" value="28.5" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9" spread="2.23"/>
                    <measurement group_id="O2" value="27.7" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.5" spread="11.16"/>
                    <measurement group_id="O2" value="32.4" spread="11.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="2.54"/>
                    <measurement group_id="O2" value="26.8" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" spread="2.23"/>
                    <measurement group_id="O2" value="27.4" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" spread="2.52"/>
                    <measurement group_id="O2" value="27.9" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="1.50"/>
                    <measurement group_id="O2" value="27.4" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)</title>
        <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.</description>
        <time_frame>At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)</title>
          <description>Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="1.08"/>
                    <measurement group_id="O2" value="5.1" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="1.71"/>
                    <measurement group_id="O2" value="4.7" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="1.22"/>
                    <measurement group_id="O2" value="5.1" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.61"/>
                    <measurement group_id="O2" value="4.8" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="1.43"/>
                    <measurement group_id="O2" value="4.7" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="0.99"/>
                    <measurement group_id="O2" value="5.3" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="1.60"/>
                    <measurement group_id="O2" value="4.6" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="1.82"/>
                    <measurement group_id="O2" value="5.0" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.22"/>
                    <measurement group_id="O2" value="4.9" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="1.04"/>
                    <measurement group_id="O2" value="4.9" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="1.20"/>
                    <measurement group_id="O2" value="5.4" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="1.75"/>
                    <measurement group_id="O2" value="4.9" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="1.78"/>
                    <measurement group_id="O2" value="4.8" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.66"/>
                    <measurement group_id="O2" value="4.7" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="0.74"/>
                    <measurement group_id="O2" value="5.0" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4</title>
          <description>Assessed by blood sample collection</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>pg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.51" spread="3.604"/>
                    <measurement group_id="O2" value="12.68" spread="4.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.30" spread="4.739"/>
                    <measurement group_id="O2" value="12.79" spread="4.381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.47" spread="4.081"/>
                    <measurement group_id="O2" value="12.31" spread="6.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="3.258"/>
                    <measurement group_id="O2" value="10.80" spread="4.201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.36" spread="5.118"/>
                    <measurement group_id="O2" value="11.85" spread="5.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.65" spread="4.465"/>
                    <measurement group_id="O2" value="12.08" spread="6.739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" spread="4.017"/>
                    <measurement group_id="O2" value="12.13" spread="4.563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.97" spread="2.608"/>
                    <measurement group_id="O2" value="11.94" spread="4.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.35" spread="3.418"/>
                    <measurement group_id="O2" value="11.95" spread="4.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4</title>
          <description>Assessed by blood sample collection</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>mIU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.672" spread="1.3376"/>
                    <measurement group_id="O2" value="1.513" spread="0.6822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.785" spread="1.0535"/>
                    <measurement group_id="O2" value="1.509" spread="0.6746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.692" spread="0.9489"/>
                    <measurement group_id="O2" value="1.422" spread="0.6528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.706" spread="1.5550"/>
                    <measurement group_id="O2" value="1.394" spread="0.8200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.726" spread="1.1633"/>
                    <measurement group_id="O2" value="1.383" spread="0.6903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.375" spread="0.8953"/>
                    <measurement group_id="O2" value="1.299" spread="0.6571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.067" spread="1.8100"/>
                    <measurement group_id="O2" value="1.325" spread="0.7248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.722" spread="1.1557"/>
                    <measurement group_id="O2" value="1.311" spread="0.5664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.801" spread="0.9463"/>
                    <measurement group_id="O2" value="1.353" spread="0.5614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)</time_frame>
        <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4</title>
          <description>Assessed by blood sample collection</description>
          <population>All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Endometrioma at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.90" spread="8.002"/>
                    <measurement group_id="O2" value="22.96" spread="6.721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="6.511"/>
                    <measurement group_id="O2" value="21.81" spread="5.481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endometrioma at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.82" spread="5.450"/>
                    <measurement group_id="O2" value="20.22" spread="5.786"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.16" spread="8.099"/>
                    <measurement group_id="O2" value="23.68" spread="6.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.01" spread="5.484"/>
                    <measurement group_id="O2" value="21.07" spread="6.526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DIE at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.98" spread="5.678"/>
                    <measurement group_id="O2" value="20.53" spread="6.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.80" spread="7.763"/>
                    <measurement group_id="O2" value="22.51" spread="4.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.17" spread="6.497"/>
                    <measurement group_id="O2" value="19.93" spread="5.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenomyosis at cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.19" spread="6.331"/>
                    <measurement group_id="O2" value="18.93" spread="4.836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 μg</title>
            <description>Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg.&#xD;
Quinagolide 1080 μg: Vaginal ring containing Quinagolide 1080 μg for daily releases</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Within 1-5 days of randomization</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.66" spread="5.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 7-14 days of randomization</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.16" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Hematocrit</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Hematocrit</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>% v/v</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.0181"/>
                    <measurement group_id="O2" value="-0.005" spread="0.0259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="5.60"/>
                    <measurement group_id="O2" value="-3.2" spread="8.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>pg/cell</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.71"/>
                    <measurement group_id="O2" value="-0.6" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="7.11"/>
                    <measurement group_id="O2" value="-4.3" spread="8.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>fL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.11"/>
                    <measurement group_id="O2" value="-0.7" spread="3.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Platelets</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Platelets</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="33.98"/>
                    <measurement group_id="O2" value="11.6" spread="45.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>10^12 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.192"/>
                    <measurement group_id="O2" value="-0.01" spread="0.228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Leukocytes</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Leukocytes</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="1.928"/>
                    <measurement group_id="O2" value="0.18" spread="2.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="5.88"/>
                    <measurement group_id="O2" value="-0.2" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Albumin</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Albumin</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="2.28"/>
                    <measurement group_id="O2" value="0.7" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>IU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="8.18"/>
                    <measurement group_id="O2" value="4.2" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="3.72"/>
                    <measurement group_id="O2" value="0.5" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="2.59"/>
                    <measurement group_id="O2" value="-2.9" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.38"/>
                    <measurement group_id="O2" value="0.0" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Bilirubin</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Bilirubin</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.84"/>
                    <measurement group_id="O2" value="-0.8" spread="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Calcium</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Calcium</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" spread="0.0896"/>
                    <measurement group_id="O2" value="0.012" spread="0.0773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Chloride</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Chloride</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.68"/>
                    <measurement group_id="O2" value="-0.5" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Cholesterol</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Cholesterol</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.045" spread="0.5050"/>
                    <measurement group_id="O2" value="0.244" spread="0.5219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Creatinine</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Creatinine</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="8.21"/>
                    <measurement group_id="O2" value="-4.3" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="4.77"/>
                    <measurement group_id="O2" value="1.0" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Glucose</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Glucose</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.734"/>
                    <measurement group_id="O2" value="-0.06" spread="0.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="12.30"/>
                    <measurement group_id="O2" value="2.8" spread="8.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Phosphate</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Phosphate</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.013" spread="0.1452"/>
                    <measurement group_id="O2" value="0.048" spread="0.1885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Potassium</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Potassium</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.333"/>
                    <measurement group_id="O2" value="0.06" spread="0.357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Sodium</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Sodium</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.04"/>
                    <measurement group_id="O2" value="0.4" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Protein</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Protein</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.82"/>
                    <measurement group_id="O2" value="1.4" spread="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Urate</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Urate</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="56.36"/>
                    <measurement group_id="O2" value="1.3" spread="37.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen</title>
          <description>Assessed by blood sample collection</description>
          <population>Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.180" spread="1.0184"/>
                    <measurement group_id="O2" value="0.148" spread="1.2286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters</title>
        <description>Assessed by blood sample collection</description>
        <time_frame>At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters</title>
          <description>Assessed by blood sample collection</description>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency and Intensity of Adverse Events</title>
        <description>Assessed by and Adverse Event Log completed by the Investigator</description>
        <time_frame>From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quinagolide 1080 µg</title>
            <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency and Intensity of Adverse Events</title>
          <description>Assessed by and Adverse Event Log completed by the Investigator</description>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were recorded for each participant from the time of signed informed consent for participation in the trial to follow-up visit (approximately 1 month after visit 8 (month 4), up to 5 months).</time_frame>
      <desc>All adverse events with onset after start of first administration of IMP and before the follow-up phone call were considered treatment-emergent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Quinagolide 1080 µg</title>
          <description>Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.&#xD;
Quinagolide 1080 µg: Vaginal ring containing Quinagolide 1080 µg for daily releases</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Vaginal ring containing matching placebo&#xD;
Placebo: Matching placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" events="15" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Compliance</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <email>DK0-Disclosure@ferring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749109
org study id: 000295
nct id: NCT03749109
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial
      investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions
      assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep
      infiltrating endometriosis, and/or adenomyosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.
measure: Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
measure: Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
measure: Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
measure: Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
measure: Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
measure: Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
description: Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
measure: Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
description: B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs.
In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3.
In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3.
The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E.
The score can be between 0 and 15.
measure: Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
description: Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:
during the last menstrual cycle
during the menstrual period of the last menstrual cycle
during the non-menstrual period of the last menstrual cycle
measure: Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
time frame: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
description: EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.
It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
measure: Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
description: Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.
measure: Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
description: Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.
measure: Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
description: Assessed by blood sample collection
measure: Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
description: Assessed by blood sample collection
measure: Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
description: Assessed by blood sample collection
measure: Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
time frame: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Platelets
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Albumin
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Calcium
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Chloride
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Creatinine
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Glucose
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Phosphate
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Potassium
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Sodium
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Protein
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Urate
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
description: Assessed by blood sample collection
measure: Frequency and Intensity of Adverse Events
time frame: From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
description: Assessed by and Adverse Event Log completed by the Investigator
arm group label: Quinagolide 1080 µg
arm group type: Experimental
description: Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Vaginal ring containing matching placebo
intervention type: Drug
intervention name: Quinagolide 1080 µg
description: Vaginal ring containing Quinagolide 1080 µg for daily releases
arm group label: Quinagolide 1080 µg
other name: FE 999051
intervention type: Drug
intervention name: Placebo
description: Matching placebo
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Germany
country: Italy
country: Poland
country: Spain
country: Switzerland
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Adenomyosis
mesh term: Quinagolide
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 