xml: <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/NCT06019533</url>
    </required_header>
    <id_info>
      <org_study_id>LR-301</org_study_id>
      <nct_id>NCT06019533</nct_id>
    </id_info>
    <brief_title>A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles</brief_title>
    <official_title>A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chemo Research</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insud Pharma</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13&#xD;
        cycles.The assessments include (but are not limited to) recording demographic data, pregnancy&#xD;
        tests, gynaecological examinations, laboratory tests and a quality of life questionnaire.&#xD;
        Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only).&#xD;
        The women will be provided with an e-diary app for their smartphone, to record IP use and&#xD;
        vaginal bleeding.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pearl Index</measure>
      <time_frame>1 year</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">750</enrollment>
    <condition>Contraception</condition>
    <arm_group>
      <arm_group_label>LVDS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>LVDS</intervention_name>
      <description>Levonorgestrel Vaginal Delivery System</description>
      <arm_group_label>LVDS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At Visit 1a, subjects must meet ALL of the following criteria:&#xD;
  &#xD;
                 1. Sexually active, postmenarcheal and premenopausal female subjects at risk of&#xD;
                    pregnancy including breastfeeding women.&#xD;
  &#xD;
                 2. Women who either&#xD;
  &#xD;
                      1. have never used hormonal contraceptives before consent/assent (naïve users),&#xD;
                         or&#xD;
  &#xD;
                      2. have used hormonal contraceptives in the past, but have had a hormonal&#xD;
                         contraceptive-free period before consent/assent and a full menstrual cycle&#xD;
                         during the drug-free period (previous users) or&#xD;
  &#xD;
                      3. directly switch from another hormonal contraceptive (switchers).&#xD;
  &#xD;
                 3. Only for subjects who were not pregnant and did not use hormonal contraception&#xD;
                    during the last 6 months before consent/assent:&#xD;
  &#xD;
          Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy or wish of pregnancy.&#xD;
  &#xD;
            2. Subject is known to or suspected of not being able to comply with the trial protocol,&#xD;
               the use of the trial medication or the use of the trial diary.&#xD;
  &#xD;
            3. History of infertility.&#xD;
  &#xD;
            4. Known bleeding disorder or history of unexplained bleeding or bruising within the last&#xD;
               12 months prior to V1a.&#xD;
  &#xD;
            5. Unexplained amenorrhoea.&#xD;
  &#xD;
            6. Abnormal finding on pelvic, breast or ultrasound examination that in the&#xD;
               investigator's opinion contraindicates participation in the trial.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elena Rojas</last_name>
      <phone>+34 676 943 642</phone>
      <email>elena.rojas@exeltis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enrico Colli</last_name>
      <email>enrico.colli@exeltis.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>LR-301/</name>
        <address>
          <city>Móstoles</city>
          <state>Madrid</state>
          <zip>28938</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019533
  org study id: LR-301
  nct id: NCT06019533
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13
        cycles.The assessments include (but are not limited to) recording demographic data, pregnancy
        tests, gynaecological examinations, laboratory tests and a quality of life questionnaire.
        Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only).
        The women will be provided with an e-diary app for their smartphone, to record IP use and
        vaginal bleeding.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Pearl Index
  time frame: 1 year
  arm group label: LVDS
  arm group type: Experimental
  intervention type: Combination Product
  intervention name: LVDS
  description: Levonorgestrel Vaginal Delivery System
  arm group label: LVDS
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 15 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elena Rojas
  phone: +34 676 943 642
  email: elena.rojas@exeltis.com
  last name: Enrico Colli
  email: enrico.colli@exeltis.com
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No