<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/NCT04457076</url>
  </required_header>
  <id_info>
    <org_study_id>CMDOC-0062</org_study_id>
    <nct_id>NCT04457076</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy, Safety, and Tolerability of LevoCept</brief_title>
  <official_title>A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCept™, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sebela Women's Health Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PRA Health Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sebela Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with&#xD;
      extension up to 5 years&#xD;
&#xD;
      Number of Subjects:&#xD;
&#xD;
      Approximately 1,525 subjects will be enrolled into the study&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and&#xD;
      who desire a long-term intrauterine contraceptive for birth control will be eligible for this&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2024</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2028</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>
    <intervention_model_description>LevoCept Intrauterine Device (IUD)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contraceptive efficacy through 3 years of use as calculated by the Pearl Index</measure>
    <time_frame>through 3 years of use</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index</measure>
    <time_frame>Years 4 and 5 and cumulatively through Years 4 and 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy percentage</measure>
    <time_frame>Years 1 through 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of LevoCept placement</measure>
    <time_frame>Day 1 / LevoCept placement</time_frame>
    <description>Ease of LevoCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LevoCept Placement success</measure>
    <time_frame>Day 1 / LevoCept placement</time_frame>
    <description>The number of subjects with either a successful or unsuccessful placement will be summarized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs and SAEs</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding and spotting patterns</measure>
    <time_frame>Through year 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insertion pain assessed immediately after insertion</measure>
    <time_frame>Day 1, immediately after insertion</time_frame>
    <description>Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative LevoCept continuation rates</measure>
    <time_frame>Years 1 through 5</time_frame>
    <description>Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative LevoCept expulsion rates</measure>
    <time_frame>Years 1 through 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant.</measure>
    <time_frame>Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy)</measure>
    <time_frame>Years 1 through 5</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1525</enrollment>
  <condition>Contraception</condition>
  <condition>Women at Risk for Pregnancy</condition>
  <arm_group>
    <arm_group_label>LevoCept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LevoCept™ Intrauterine Contraceptive</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LevoCept</intervention_name>
    <description>Levonorgestrel-Releasing Intrauterine System</description>
    <arm_group_label>LevoCept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed&#xD;
             consent/assent and in good general health;&#xD;
&#xD;
          2. History of regular menstrual cycles defined as occurring every 21-35 days when not&#xD;
             using hormones or prior to recent pregnancy or spontaneous or induced abortion;&#xD;
&#xD;
          3. Sexually active with a male partner who has not had a vasectomy nor other known&#xD;
             fertility problems;&#xD;
&#xD;
          4. Reasonably expect to have coitus at least once monthly during the study period;&#xD;
&#xD;
          5. In a mutually monogamous relationship of at least 3 months duration at time of&#xD;
             consent;&#xD;
&#xD;
          6. Seeking to avoid pregnancy for the duration of the study;&#xD;
&#xD;
          7. Willing to use the study drug as the sole form of contraception;&#xD;
&#xD;
          8. Willing to accept a risk of pregnancy;&#xD;
&#xD;
          9. Subjects must be in compliance with cervical cancer screening guidelines per the&#xD;
             American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without&#xD;
             evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent,&#xD;
             must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined&#xD;
             significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects&#xD;
             who are 25 or older at the time of informed consent must have a normal Pap test or an&#xD;
             ASC-US result with a negative high-risk human papilloma virus (HPV) test result within&#xD;
             the appropriate screen timeframe per ASCCP guidelines, and prior to the study IUD&#xD;
             insertion. Alternatively, the subject must have had a colposcopy performed within the&#xD;
             appropriate screen timeframe, and prior to the study IUD insertion that showed no&#xD;
             evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was&#xD;
             performed and follow-up at least 6 months after the treatment showed no evidence of&#xD;
             disease by clinical evaluation;&#xD;
&#xD;
         10. Able and willing to comply with all study tests, procedures, assessment tools&#xD;
             (including e-diary) and follow-up;&#xD;
&#xD;
         11. Able and willing to provide and document informed consent and Authorization for&#xD;
             Release of Protected Health Information (PHI). Unemancipated subjects under 18 years&#xD;
             old must provide assent and have written parental/legal guardian consent documented on&#xD;
             the consent form consistent with local legal requirements;&#xD;
&#xD;
         12. Plan to reside within a reasonable travel distance of a research site for the duration&#xD;
             of the study.&#xD;
&#xD;
         13. Subject agrees not to intentionally self-remove LevoCept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse&#xD;
             earlier in current cycle;&#xD;
&#xD;
          2. Has had any procedure for or causing sterility (e.g. tubal ligation procedure);&#xD;
&#xD;
          3. Subject who anticipates separation from her partner for more than a 6-month period&#xD;
             during use of LevoCept;&#xD;
&#xD;
          4. A previously inserted IUD/IUS that has not been removed by the time the study IUS is&#xD;
             placed;&#xD;
&#xD;
          5. History of previous IUD/IUS complications, such as perforation, expulsion, or&#xD;
             pregnancy with IUD/IUS in place;&#xD;
&#xD;
          6. Pain with current IUD/IUS;&#xD;
&#xD;
          7. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and&#xD;
             has not had 2 normal menstrual cycles since the last injection;&#xD;
&#xD;
          8. Subject is &lt;4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)&#xD;
&#xD;
          9. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time&#xD;
             during the 60 months of study participation;&#xD;
&#xD;
         10. Exclusively breastfeeding before return of menses; lactating women will be excluded&#xD;
             unless they have had 2 normal menstrual periods prior to enrollment;&#xD;
&#xD;
         11. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including&#xD;
             bleeding 4 weeks post-septic abortion or puerperal sepsis;&#xD;
&#xD;
         12. Severely heavy or painful menstrual bleeding;&#xD;
&#xD;
         13. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically&#xD;
             significant abnormal Pap test requiring evaluation or treatment;&#xD;
&#xD;
         14. Any history of gestational trophoblastic disease with or without detectable elevated&#xD;
             ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;&#xD;
&#xD;
         15. Any congenital or acquired uterine anomaly that may complicate study drug placement,&#xD;
             such as:&#xD;
&#xD;
               -  Submucosal uterine leiomyoma&#xD;
&#xD;
               -  Asherman's syndromes&#xD;
&#xD;
               -  Pedunculated polyps&#xD;
&#xD;
               -  Bicornuate uterus&#xD;
&#xD;
               -  Didelphus or uterine septa&#xD;
&#xD;
         16. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the&#xD;
             investigator, are likely to cause issues during insertion, retention or removal of the&#xD;
             IUS;&#xD;
&#xD;
         17. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior&#xD;
             trachelectomy or extensive conization that, in the opinion of the investigator would&#xD;
             prevent cervical dilation and study drug placement;&#xD;
&#xD;
         18. Untreated or unresolved acute cervicitis or vaginitis;&#xD;
&#xD;
         19. Known or suspected breast cancer or other progestin-sensitive cancer now or in the&#xD;
             past;&#xD;
&#xD;
         20. Known acute liver disease or liver tumor;&#xD;
&#xD;
         21. Subjects who have an established immunodeficiency;&#xD;
&#xD;
         22. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;&#xD;
&#xD;
         23. At high risk for sexually transmitted infections (e.g. multiple sexual partners);&#xD;
&#xD;
         24. Known intolerance or allergy to any components of LevoCept, including intolerance or&#xD;
             allergy to levonorgestrel, nickel, titanium, or silicone;&#xD;
&#xD;
         25. Currently participating or planning future participation in a research study of an&#xD;
             investigational drug or device during the course of this investigational study.&#xD;
             Subject must have waited at least 30 days from exiting their last study prior to&#xD;
             informed consent in this study;&#xD;
&#xD;
         26. Subject has previously been enrolled in a VeraCept or LevoCept study (including the&#xD;
             current study);&#xD;
&#xD;
         27. Known or suspected alcohol or drug abuse within 12 months prior to the screening&#xD;
             visit;&#xD;
&#xD;
         28. Any general health, mental health or behavioral condition that, in the opinion of the&#xD;
             investigator, could represent an increased risk for the subject or would render the&#xD;
             subject less likely to provide the needed study information;&#xD;
&#xD;
         29. Study staff or a member of the immediate family of study staff.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Essential Access Health-Berkeley</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94710</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Amber Van Kessel</last_name>
      <phone>213-386-5614</phone>
      <phone_ext>2205</phone_ext>
      <email>avankessel@essentialaccess.org</email>
    </contact>
    <contact_backup>
      <last_name>Jade Aganus</last_name>
      <phone>213-386-5614</phone>
      <phone_ext>2205</phone_ext>
      <email>aaganus@essentialaccess.org</email>
    </contact_backup>
    <investigator>
      <last_name>Fung Lam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Essential Access Health-Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90010</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Seline Guidotti</last_name>
      <phone>213-386-5614</phone>
      <phone_ext>4500</phone_ext>
      <email>sguidotti@essentialaccess.org</email>
    </contact>
    <contact_backup>
      <last_name>Anna Garcia</last_name>
      <phone>213-386-5614</phone>
      <phone_ext>4596</phone_ext>
      <email>agarcia@essentialaccess.org</email>
    </contact_backup>
    <investigator>
      <last_name>Anita Nelson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health System Department of Obstetrics and Gynecology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>UC Davis ObGyn Research</last_name>
      <phone>916-734-6846</phone>
      <email>hs-obgynresearch@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Mitchell Creinin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>WR-Medical Center for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Merrilee Fleet</last_name>
      <phone>919-645-9225</phone>
      <email>mfleet@wakeresearch.com</email>
    </contact>
    <contact_backup>
      <last_name>Jessica Backus</last_name>
      <phone>858-987-2219</phone>
      <email>jbackus@mccresearch.com</email>
    </contact_backup>
    <investigator>
      <last_name>Denis Tarakjian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Women's Health Care Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92111</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Rovena Reagan, MD</last_name>
      <phone>858-505-8672</phone>
      <email>information@whcresearch.com</email>
    </contact>
    <investigator>
      <last_name>Rovena Reagan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University, Medical Center, Obstetrics and Gynecolocy</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Tayler Hughes</last_name>
      <phone>650-721-1237</phone>
      <email>birthcontrol@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kathryn Bathem</last_name>
      <phone>650-724-7826</phone>
      <email>gynresearch@stanford.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Paul Blumenthal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Of Colorado Department of Obstetrics &amp; Gyncology</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downtown Women's Health Care</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine Gynecology/Obstetrics</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Valerie Jean</last_name>
      <phone>404-778-1373</phone>
      <email>familyplanning@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Tiffany Hailstorks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Soapstone Center for Clinical Research</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30034</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Natalie Hinton</last_name>
      <phone>404-534-9359</phone>
      <email>nhinton4sccr@aol.com</email>
    </contact>
    <contact_backup>
      <last_name>Sarah Holmes</last_name>
      <phone>404-534-9359</phone>
      <email>sholmes4sccr@aol.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sonya Marks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Hawaii</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Emory Bowen</last_name>
      <phone>808-203-6574</phone>
      <email>ebowen@ucera.org</email>
    </contact>
    <contact_backup>
      <last_name>Jasmine Tyson</last_name>
      <phone>808-203-6594</phone>
      <email>jasminetyson@ucera.org</email>
    </contact_backup>
    <investigator>
      <last_name>Bliss Kaneshiro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Women's Health Advantage</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Teresa Brousseau</last_name>
      <phone>260-432-4400</phone>
      <phone_ext>6367</phone_ext>
      <email>tbrousseau@isapin.com</email>
    </contact>
    <investigator>
      <last_name>Tracy Bellavance, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IU Health University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Kathleen Wendholt</last_name>
      <phone>317-948-0796</phone>
      <email>schmittk@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Morgan Runkel</last_name>
      <phone>317-948-7587</phone>
      <email>mlrunkel@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jeffrey Peipert, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood North Central States</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55408</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Bridge McKye</last_name>
      <phone>651-389-0675</phone>
      <email>bmckye@ppncs.org</email>
    </contact>
    <contact_backup>
      <last_name>Marcy Thomas</last_name>
      <phone>651-237-4046</phone>
      <email>mthomas@ppncs.org</email>
    </contact_backup>
    <investigator>
      <last_name>Christy Boraas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood of the St. Louis Region and Southwest Missouri</name>
      <address>
        <city>Manchester</city>
        <state>Missouri</state>
        <zip>63088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Garn Mabey Jr., MD</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati/Reproductive Medicine Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Ob/Gyn Research Office</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Philadelphia, LLC</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee-Womens Hospital, Center for Family Planning Research</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advances In Health</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Healthcare Health Sciences Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Physicians for Women</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Women's: Health, Research, Gynecology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contraception</keyword>
  <keyword>IUD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04457076
org study id: CMDOC-0062
nct id: NCT04457076
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
Study Design:

      Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with
      extension up to 5 years

      Number of Subjects:

      Approximately 1,525 subjects will be enrolled into the study

      Study Population:

      Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and
      who desire a long-term intrauterine contraceptive for birth control will be eligible for this
      study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: LevoCept Intrauterine Device (IUD)
primary purpose: Treatment
masking: None (Open Label)
measure: Contraceptive efficacy through 3 years of use as calculated by the Pearl Index
time frame: through 3 years of use
measure: Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index
time frame: Years 4 and 5 and cumulatively through Years 4 and 5
measure: Pregnancy percentage
time frame: Years 1 through 5
measure: Ease of LevoCept placement
time frame: Day 1 / LevoCept placement
description: Ease of LevoCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).
measure: LevoCept Placement success
time frame: Day 1 / LevoCept placement
description: The number of subjects with either a successful or unsuccessful placement will be summarized
measure: Incidence of AEs and SAEs
time frame: 5 years
measure: Bleeding and spotting patterns
time frame: Through year 1
measure: Insertion pain assessed immediately after insertion
time frame: Day 1, immediately after insertion
description: Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain
measure: Cumulative LevoCept continuation rates
time frame: Years 1 through 5
description: Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.
measure: Cumulative LevoCept expulsion rates
time frame: Years 1 through 5
measure: Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant.
time frame: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
measure: Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy)
time frame: Years 1 through 5
arm group label: LevoCept
arm group type: Experimental
description: LevoCept™ Intrauterine Contraceptive
intervention type: Drug
intervention name: LevoCept
description: Levonorgestrel-Releasing Intrauterine System
arm group label: LevoCept
criteria: 
gender: Female
minimum age: N/A
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
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country: United States
responsible party type: Sponsor
sharing ipd: No