<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/NCT03785366</url>
  </required_header>
  <id_info>
    <org_study_id>CMDOC-0045</org_study_id>
    <nct_id>NCT03785366</nct_id>
  </id_info>
  <brief_title>A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)</brief_title>
  <acronym>IUD</acronym>
  <official_title>A Randomized, Single-Blind, Comparative Bioavailability Study to Assess the Pharmacokinetic Properties of VeraCept™ Intrauterine Contraceptive vs ParaGard® in Healthy, Post-Menarcheal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sebela Women's Health Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Synteract, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sebela Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      to Assess the Pharmacokinetic Properties of VeraCept™ Intrauterine Contraceptive vs ParaGard®&#xD;
      in Healthy, Post- Menarcheal Women&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects are blinded until the Day 57 Visit</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Observed systemic copper bioavailability of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed systemic copper bioavailability of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmean</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed systemic copper bioavailability of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Area Under the Curve (AUC)0-56 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline-corrected total serum copper of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-corrected total serum copper of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on Cmean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-corrected total serum copper of VeraCept vs. ParaGard</measure>
    <time_frame>through Day 56</time_frame>
    <description>To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare total serum copper levels of VeraCept vs. ParaGard compared to normal copper levels</measure>
    <time_frame>through Day 56 for ParaGard and through Year-5 for VeraCept</time_frame>
    <description>To assess the total serum copper levels within each treatment relative to the normal range (49 to 184 µg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term stability of copper levels as determined by Cmax - VeraCept only</measure>
    <time_frame>At Year 3 and Year 5 as determined by PK samples drawn at each visit</time_frame>
    <description>To assess the long-term stability of copper levels following insertion of the VeraCept IUD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Women at Risk for Pregnancy</condition>
  <arm_group>
    <arm_group_label>VeraCept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ParaGard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VeraCept</intervention_name>
    <description>VeraCept Intrauterine Device (IUD)</description>
    <arm_group_label>VeraCept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ParaGard</intervention_name>
    <description>ParaGard intrauterine copper contraceptive</description>
    <arm_group_label>ParaGard</arm_group_label>
    <other_name>ParaGard T 380A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  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;
          -  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;
          -  Sexually active with a male partner who has not had a vasectomy;&#xD;
&#xD;
          -  Reasonably expect to have coitus at least once monthly during the study period;&#xD;
&#xD;
          -  In a mutually monogamous relationship of at least 3 months duration;&#xD;
&#xD;
          -  Seeking to avoid pregnancy for the duration of the study;&#xD;
&#xD;
          -  Willing to use the study drug as the sole form of contraception;&#xD;
&#xD;
          -  Willing to accept a risk of pregnancy;&#xD;
&#xD;
          -  Subjects who are age 21 or older, at time of informed consent, must have a normal&#xD;
             papanicolaou test (Pap) or atypical squamous cells of undetermined significance&#xD;
             (ASC-US) with negative high risk human papilloma virus (HPV) test result within the&#xD;
             appropriate screen timeframe per American Society for Colposcopy and Cervical&#xD;
             Pathology (ASCCP) guidelines, and prior to the study IUD insertion. Alternatively, the&#xD;
             subject must have had a colposcopy performed within the appropriate screen timeframe,&#xD;
             and prior to the study IUD insertion that showed no evidence of dysplasia requiring&#xD;
             treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6&#xD;
             months after the treatment showed no evidence of disease by clinical evaluation;&#xD;
&#xD;
          -  Able and willing to comply with all study tests, procedures, assessment tools and&#xD;
             follow-up;&#xD;
&#xD;
          -  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 consent documented on the consent&#xD;
             form consistent with local legal requirements;&#xD;
&#xD;
          -  Plan to reside within a reasonable driving distance of a research site for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Subject agrees not to self-remove VeraCept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse&#xD;
             earlier in current cycle;&#xD;
&#xD;
          -  A previously inserted intrauterine device (IUD) that has not been removed by the time&#xD;
             the study IUD is placed;&#xD;
&#xD;
          -  History of previous IUD complications, such as perforation, expulsion, or pregnancy&#xD;
             with IUD in place;&#xD;
&#xD;
          -  Pain with current IUD;&#xD;
&#xD;
          -  Use of ParaGard IUD within the past 3 months&#xD;
&#xD;
          -  Planned use of any non-contraceptive estrogen, progesterone or testosterone any time&#xD;
             during the 60 months of study participation;&#xD;
&#xD;
          -  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;
          -  Unexplained abnormal uterine bleeding (suspicious for a serious condition), including&#xD;
             bleeding 4 weeks post-septic abortion or puerperal sepsis;&#xD;
&#xD;
          -  Severely heavy or painful menstrual bleeding;&#xD;
&#xD;
          -  Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically&#xD;
             significant abnormal Pap smear requiring evaluation or treatment;&#xD;
&#xD;
          -  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;
          -  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;
          -  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;
             IUD;&#xD;
&#xD;
          -  Untreated acute cervicitis or vaginitis within the past 3 months;&#xD;
&#xD;
          -  Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;&#xD;
&#xD;
          -  Subjects who have an established immunodeficiency;&#xD;
&#xD;
          -  Known intolerance or allergy to any components of VeraCept or ParaGard including&#xD;
             intolerance or allergy to nickel, titanium, or copper, and including Wilson's Disease;&#xD;
&#xD;
          -  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;
          -  Subject has been enrolled in a previous VeraCept study;&#xD;
&#xD;
          -  Known or suspected alcohol or drug abuse within 12 months prior to the screening&#xD;
             visit;&#xD;
&#xD;
          -  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;
          -  Study staff or a member of the immediate family of study staff.&#xD;
&#xD;
          -  Concurrent use of corticosteroids&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>OHSU Women's Health Research Unit</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Women's Health</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03785366
org study id: CMDOC-0045
nct id: NCT03785366
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
to Assess the Pharmacokinetic Properties of VeraCept™ Intrauterine Contraceptive vs ParaGard®
      in Healthy, Post- Menarcheal Women
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
masking description: Subjects are blinded until the Day 57 Visit
measure: Observed systemic copper bioavailability of VeraCept vs. ParaGard
time frame: through Day 56
description: Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax
measure: Observed systemic copper bioavailability of VeraCept vs. ParaGard
time frame: through Day 56
description: Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmean
measure: Observed systemic copper bioavailability of VeraCept vs. ParaGard
time frame: through Day 56
description: Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Area Under the Curve (AUC)0-56 days
measure: Baseline-corrected total serum copper of VeraCept vs. ParaGard
time frame: through Day 56
description: To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on Cmax
measure: Baseline-corrected total serum copper of VeraCept vs. ParaGard
time frame: through Day 56
description: To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on Cmean
measure: Baseline-corrected total serum copper of VeraCept vs. ParaGard
time frame: through Day 56
description: To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days
measure: Compare total serum copper levels of VeraCept vs. ParaGard compared to normal copper levels
time frame: through Day 56 for ParaGard and through Year-5 for VeraCept
description: To assess the total serum copper levels within each treatment relative to the normal range (49 to 184 µg/dL).
measure: Long-term stability of copper levels as determined by Cmax - VeraCept only
time frame: At Year 3 and Year 5 as determined by PK samples drawn at each visit
description: To assess the long-term stability of copper levels following insertion of the VeraCept IUD
arm group label: VeraCept
arm group type: Experimental
description: VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
arm group label: ParaGard
arm group type: Active Comparator
description: ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
intervention type: Drug
intervention name: VeraCept
description: VeraCept Intrauterine Device (IUD)
arm group label: VeraCept
intervention type: Drug
intervention name: ParaGard
description: ParaGard intrauterine copper contraceptive
arm group label: ParaGard
other name: ParaGard T 380A
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor