<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/NCT01709318</url>
  </required_header>
  <id_info>
    <org_study_id>P06109</org_study_id>
    <secondary_id>2012-002459-41</secondary_id>
    <secondary_id>P06109</secondary_id>
    <secondary_id>MK-8175A/MK-8342B-012</secondary_id>
    <nct_id>NCT01709318</nct_id>
  </id_info>
  <brief_title>A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)</brief_title>
  <official_title>A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either Nomegestrol Acetate or Etonogestrel in Healthy Women Aged 18-35 Years. Protocol MK-8175A/MK-8342B 012</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this trial was to identify at least one next generation ring (NGR)&#xD;
      that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of&#xD;
      participants ovulation was observed in less than 15% of the participants at any time during&#xD;
      the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as&#xD;
      judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The&#xD;
      primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and&#xD;
      cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the&#xD;
      incidence of BTB-S.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2012</start_date>
  <completion_date type="Actual">October 22, 2013</completion_date>
  <primary_completion_date type="Actual">October 22, 2013</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>Percentage of Participants With Ovulation Incidence, by Cycle</measure>
    <time_frame>Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)</time_frame>
    <description>Ovulation was defined as having 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure &gt;15 mm in size).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Progesterone Concentrations &gt;16 Nmol/L, by Cycle</measure>
    <time_frame>Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)</time_frame>
    <description>Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3</measure>
    <time_frame>Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)</time_frame>
    <description>Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2</measure>
    <time_frame>Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)</time_frame>
    <description>Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Withdrawal Bleeding During Cycle 2</measure>
    <time_frame>Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)</time_frame>
    <description>Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3</measure>
    <time_frame>Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)</time_frame>
    <description>Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced At Least One Adverse Event</measure>
    <time_frame>Up to ~92 days</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced At Least One Serious Adverse Event</measure>
    <time_frame>Up to ~92 days</time_frame>
    <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event</measure>
    <time_frame>Up to ~92 days</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Any Drug-Related Serious Adverse Event</measure>
    <time_frame>Up to ~92 days</time_frame>
    <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to ~92 days</time_frame>
    <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events</measure>
    <time_frame>From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)</time_frame>
    <description>Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.</description>
  </other_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">666</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NuvaRing®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nomegestrol acetate (NOMAC)</intervention_name>
    <description>Daily release of 500, 700, or 900 μg.</description>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day</arm_group_label>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day</arm_group_label>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etonogestrel (ENG)</intervention_name>
    <description>Daily release of 75, 100, 120 or 125 μg</description>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day</arm_group_label>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day</arm_group_label>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day</arm_group_label>
    <arm_group_label>NuvaRing®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethinyl estradiol (EE)</intervention_name>
    <description>Daily release of 15 μg</description>
    <arm_group_label>NuvaRing®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol (E2)</intervention_name>
    <description>Daily release of 300 μg</description>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day</arm_group_label>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day</arm_group_label>
    <arm_group_label>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day</arm_group_label>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day</arm_group_label>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day</arm_group_label>
    <arm_group_label>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) ≥18 and ≤35&#xD;
&#xD;
          -  Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3&#xD;
             days permitted within this range&#xD;
&#xD;
          -  Good physical and mental health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus with vascular involvement&#xD;
&#xD;
          -  Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis&#xD;
&#xD;
          -  Severe dyslipoproteinemia&#xD;
&#xD;
          -  Severe hypertension&#xD;
&#xD;
          -  Presence or history of pancreatitis associated with severe hypertriglyceridaemia&#xD;
&#xD;
          -  Presence or history of severe hepatic disease&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Participation in another investigational drug study within 30 days prior to screening&#xD;
             visit&#xD;
&#xD;
          -  History of malignancy ≤5 years, except for adequately treated basal cell or squamous&#xD;
             cell skin cancer, or in situ cervical cancer&#xD;
&#xD;
          -  Documented abnormal cervical smear result in 6 months prior to screening visit&#xD;
&#xD;
          -  Sterilization using a fallopian tube occlusion device (e.g., Essure method)&#xD;
&#xD;
          -  Sex hormone therapy within 2 months prior to screening visit for purpose other than&#xD;
             contraception, or injectable hormonal contraception within 6 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Spain</country>
  </removed_countries>
  <results_reference>
    <citation>Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11.</citation>
    <PMID>30203681</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>November 14, 2019</results_first_submitted>
  <results_first_submitted_qc>November 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 5, 2019</results_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Etonogestrel</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study enrolled healthy female participants aged 18 to 35 years, with cycles between 24 to 35 days in length.</recruitment_details>
      <pre_assignment_details>Of the 757 participants who were screened for inclusion in the trial, 666 participants were randomized, and 660 participants were treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P2">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P3">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P4">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P5">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P6">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="P7">
          <title>NuvaRing®</title>
          <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="78"/>
                <participants group_id="P5" count="78"/>
                <participants group_id="P6" count="84"/>
                <participants group_id="P7" count="182"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="78"/>
                <participants group_id="P4" count="77"/>
                <participants group_id="P5" count="77"/>
                <participants group_id="P6" count="86"/>
                <participants group_id="P7" count="178"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="72"/>
                <participants group_id="P5" count="74"/>
                <participants group_id="P6" count="80"/>
                <participants group_id="P7" count="171"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical Problems</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Protocol Specified Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>4 participants used the incorrect vaginal ring per the randomization schedule throughout the trial (2 participants in ENG-E2 125/300 μg and 1 participant each in the NOMAC-E2 900/300 μg and NuvaRing group).</population>
      <group_list>
        <group group_id="B1">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B2">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B3">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B4">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B5">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B6">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B7">
          <title>NuvaRing®</title>
          <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="B8">
          <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="79"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="78"/>
            <count group_id="B4" value="77"/>
            <count group_id="B5" value="77"/>
            <count group_id="B6" value="86"/>
            <count group_id="B7" value="178"/>
            <count group_id="B8" value="660"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="26.7" spread="5.02"/>
                    <measurement group_id="B2" value="26.7" spread="4.91"/>
                    <measurement group_id="B3" value="26.1" spread="4.46"/>
                    <measurement group_id="B4" value="25.5" spread="4.87"/>
                    <measurement group_id="B5" value="26.1" spread="4.52"/>
                    <measurement group_id="B6" value="27.1" spread="4.61"/>
                    <measurement group_id="B7" value="25.9" spread="4.82"/>
                    <measurement group_id="B8" value="26.3" spread="4.76"/>
                  </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="79"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="77"/>
                    <measurement group_id="B5" value="77"/>
                    <measurement group_id="B6" value="86"/>
                    <measurement group_id="B7" value="178"/>
                    <measurement group_id="B8" value="660"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" 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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                  </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 group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="77"/>
                    <measurement group_id="B6" value="85"/>
                    <measurement group_id="B7" value="174"/>
                    <measurement group_id="B8" value="645"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="8"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Ovulation Incidence, by Cycle</title>
        <description>Ovulation was defined as having 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure &gt;15 mm in size).</description>
        <time_frame>Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and received ultrasound and hormonal assessments, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Ovulation Incidence, by Cycle</title>
          <description>Ovulation was defined as having 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure &gt;15 mm in size).</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and received ultrasound and hormonal assessments, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="63"/>
                <count group_id="O6" value="65"/>
                <count group_id="O7" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Progesterone Concentrations &gt;16 Nmol/L, by Cycle</title>
        <description>Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.</description>
        <time_frame>Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and received hormonal assessment for progesterone concentration, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Progesterone Concentrations &gt;16 Nmol/L, by Cycle</title>
          <description>Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations &gt;16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and received hormonal assessment for progesterone concentration, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="63"/>
                <count group_id="O6" value="65"/>
                <count group_id="O7" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Max P &gt; 16 nmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="19"/>
                    <count group_id="O7" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Max P &gt; 16 nmol/L</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 group_id="O3" value="16"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="17"/>
                    <count group_id="O7" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Max P &gt; 16 nmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="17"/>
                    <count group_id="O7" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3</title>
        <description>Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
        <time_frame>Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3</title>
          <description>Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="49"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="13.3"/>
                    <measurement group_id="O3" value="17.5"/>
                    <measurement group_id="O4" value="13.6"/>
                    <measurement group_id="O5" value="16.3"/>
                    <measurement group_id="O6" value="6.4"/>
                    <measurement group_id="O7" value="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>8.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>26.5</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>6.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>24.8</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>12.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>33.1</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>6.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>25.4</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>9.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>27.4</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.7</ci_lower_limit>
            <ci_upper_limit>15.9</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2</title>
        <description>Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
        <time_frame>Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2</title>
          <description>Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="45"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="54"/>
                <count group_id="O6" value="52"/>
                <count group_id="O7" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="1.9"/>
                    <measurement group_id="O3" value="4.4"/>
                    <measurement group_id="O4" value="7.8"/>
                    <measurement group_id="O5" value="3.7"/>
                    <measurement group_id="O6" value="1.9"/>
                    <measurement group_id="O7" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.6</ci_lower_limit>
            <ci_upper_limit>16.4</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>11.0</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>3.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>17.5</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>4.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>18.9</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.0</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.</non_inferiority_desc>
            <param_type>Difference in Percent</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>11.0</ci_upper_limit>
            <estimate_desc>95% CI adjusted for multiplicity (Dunnett)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Withdrawal Bleeding During Cycle 2</title>
        <description>Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
        <time_frame>Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one withdrawal bleeding or spotting day, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Withdrawal Bleeding During Cycle 2</title>
          <description>Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one withdrawal bleeding or spotting day, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="52"/>
                <count group_id="O6" value="51"/>
                <count group_id="O7" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.25"/>
                    <measurement group_id="O2" value="0.92" spread="0.17"/>
                    <measurement group_id="O3" value="0.86" spread="0.19"/>
                    <measurement group_id="O4" value="0.90" spread="0.18"/>
                    <measurement group_id="O5" value="0.92" spread="0.18"/>
                    <measurement group_id="O6" value="0.93" spread="0.14"/>
                    <measurement group_id="O7" value="0.95" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.096</p_value>
            <method>LDA</method>
            <param_type>Difference of Least Squares (LS) Mean</param_type>
            <param_value>-0.08</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.993</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.03</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.124</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.08</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.845</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.05</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.976</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.04</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.995</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.03</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3</title>
        <description>Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
        <time_frame>Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)</time_frame>
        <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one breakthrough bleeding and/or spotting day, excluding protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3</title>
          <description>Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.</description>
          <population>The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one breakthrough bleeding and/or spotting day, excluding protocol violators in terms of ring use, daily diary entry or prohibited medications.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.45"/>
                    <measurement group_id="O2" value="0.80" spread="0.40"/>
                    <measurement group_id="O3" value="0.68" spread="0.47"/>
                    <measurement group_id="O4" value="0.73" spread="0.16"/>
                    <measurement group_id="O5" value="0.67" spread="0.43"/>
                    <measurement group_id="O6" value="0.33" spread="0.58"/>
                    <measurement group_id="O7" value="0.67" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>1.000</p_value>
            <method>LDA</method>
            <param_type>Difference of Least Squares (LS) Mean</param_type>
            <param_value>-0.01</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.996</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>0.19</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>1.000</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.06</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>1.000</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.04</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>1.000</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>0.09</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.</non_inferiority_desc>
            <p_value>0.998</p_value>
            <method>LDA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-0.24</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events</title>
        <description>Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.</description>
        <time_frame>From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events</title>
          <description>Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                    <measurement group_id="O6" value="0.0"/>
                    <measurement group_id="O7" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced At Least One Adverse Event</title>
        <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
        <time_frame>Up to ~92 days</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced At Least One Adverse Event</title>
          <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.0"/>
                    <measurement group_id="O2" value="40.0"/>
                    <measurement group_id="O3" value="43.6"/>
                    <measurement group_id="O4" value="37.7"/>
                    <measurement group_id="O5" value="39.0"/>
                    <measurement group_id="O6" value="46.5"/>
                    <measurement group_id="O7" value="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced At Least One Serious Adverse Event</title>
        <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.</description>
        <time_frame>Up to ~92 days</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced At Least One Serious Adverse Event</title>
          <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                    <measurement group_id="O6" value="0.0"/>
                    <measurement group_id="O7" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event</title>
        <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
        <time_frame>Up to ~92 days</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event</title>
          <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6"/>
                    <measurement group_id="O2" value="23.5"/>
                    <measurement group_id="O3" value="26.9"/>
                    <measurement group_id="O4" value="29.9"/>
                    <measurement group_id="O5" value="26.0"/>
                    <measurement group_id="O6" value="31.4"/>
                    <measurement group_id="O7" value="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Any Drug-Related Serious Adverse Event</title>
        <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
        <time_frame>Up to ~92 days</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Drug-Related Serious Adverse Event</title>
          <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                    <measurement group_id="O6" value="0.0"/>
                    <measurement group_id="O7" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
        <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
        <time_frame>Up to ~92 days</time_frame>
        <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
        <group_list>
          <group group_id="O1">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O2">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O3">
            <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
            <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O4">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O5">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O6">
            <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
            <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
          <group group_id="O7">
            <title>NuvaRing®</title>
            <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
          <description>An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.</description>
          <population>The analysis population included all randomized participants in whom a vaginal ring was inserted.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="85"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="77"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="4.7"/>
                    <measurement group_id="O3" value="2.6"/>
                    <measurement group_id="O4" value="2.6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1.2"/>
                    <measurement group_id="O7" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to ~92 days</time_frame>
      <desc>The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E2">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E3">
          <title>Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day</title>
          <description>Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E4">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E5">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E6">
          <title>Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day</title>
          <description>Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
        <group group_id="E7">
          <title>NuvaRing®</title>
          <description>Participants received NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.</description>
        </group>
      </group_list>
      <serious_events>
        <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="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="23" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="85"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="78"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="77"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="86"/>
                <counts group_id="E7" subjects_affected="46" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="86"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E7" events="8" subjects_affected="7" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="85"/>
                <counts group_id="E3" events="13" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E4" events="14" subjects_affected="11" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="77"/>
                <counts group_id="E6" events="9" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E7" events="18" subjects_affected="16" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E7" events="8" subjects_affected="4" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="24" subjects_affected="12" subjects_at_risk="79"/>
                <counts group_id="E2" events="21" subjects_affected="11" subjects_at_risk="85"/>
                <counts group_id="E3" events="43" subjects_affected="14" subjects_at_risk="78"/>
                <counts group_id="E4" events="35" subjects_affected="13" subjects_at_risk="77"/>
                <counts group_id="E5" events="29" subjects_affected="15" subjects_at_risk="77"/>
                <counts group_id="E6" events="35" subjects_affected="13" subjects_at_risk="86"/>
                <counts group_id="E7" events="47" subjects_affected="24" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E7" events="11" subjects_affected="7" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="85"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="86"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="85"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E6" events="10" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="178"/>
              </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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01709318
org study id: P06109
secondary id: 2012-002459-41
secondary id: P06109
secondary id: MK-8175A/MK-8342B-012
nct id: NCT01709318
lead sponsor: 
has dmc: No
The primary objective of this trial was to identify at least one next generation ring (NGR)
      that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of
      participants ovulation was observed in less than 15% of the participants at any time during
      the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as
      judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The
      primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and
      cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the
      incidence of BTB-S.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Ovulation Incidence, by Cycle
time frame: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
description: Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size).
measure: Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
time frame: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
description: Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.
measure: Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
time frame: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)
description: Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
measure: Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
time frame: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
description: Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
measure: Intensity of Withdrawal Bleeding During Cycle 2
time frame: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
description: Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
measure: Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
time frame: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)
description: Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
measure: Percentage of Participants Who Experienced At Least One Adverse Event
time frame: Up to ~92 days
description: An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
measure: Percentage of Participants Who Experienced At Least One Serious Adverse Event
time frame: Up to ~92 days
description: A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.
measure: Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event
time frame: Up to ~92 days
description: An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
measure: Percentage of Participants With Any Drug-Related Serious Adverse Event
time frame: Up to ~92 days
description: A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
time frame: Up to ~92 days
description: An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
measure: Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events
time frame: From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)
description: Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day
arm group type: Experimental
description: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day
arm group type: Experimental
description: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day
arm group type: Experimental
description: Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day
arm group type: Experimental
description: Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day
arm group type: Experimental
description: Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day
arm group type: Experimental
description: Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
arm group label: NuvaRing®
arm group type: Active Comparator
description: Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol [ENG-EE] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
intervention type: Drug
intervention name: Nomegestrol acetate (NOMAC)
description: Daily release of 500, 700, or 900 μg.
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day
intervention type: Drug
intervention name: Etonogestrel (ENG)
description: Daily release of 75, 100, 120 or 125 μg
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day
arm group label: NuvaRing®
intervention type: Drug
intervention name: Ethinyl estradiol (EE)
description: Daily release of 15 μg
arm group label: NuvaRing®
intervention type: Drug
intervention name: Estradiol (E2)
description: Daily release of 300 μg
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day
arm group label: Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day
arm group label: Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Denmark
country: Germany
country: Hungary
country: Netherlands
country: Norway
country: Poland
country: Spain
citation: Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11.
PMID: 30203681
responsible party type: Sponsor
mesh term: Uterine Hemorrhage
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Ethinyl Estradiol
mesh term: Etonogestrel
mesh term: Estradiol
mesh term: Polyestradiol phosphate
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 