<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/NCT03243305</url>
  </required_header>
  <id_info>
    <org_study_id>AMP002</org_study_id>
    <nct_id>NCT03243305</nct_id>
  </id_info>
  <brief_title>AMP002 Phase III Contraceptive Study</brief_title>
  <official_title>AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal Gel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evofem Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Evofem 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>
      This is a single-arm, open-label, Phase III study in approximately 100 sites in the United&#xD;
      States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through assessments including pelvic examination, laboratory procedures, and medical and&#xD;
      gynecological history, subjects will be screened for eligibility in order to enroll&#xD;
      approximately 1349 subjects into the study. After a screening period of up to 60 days,&#xD;
      enrolled women will receive study drug. Each woman will participate in the study until after&#xD;
      she has completed treatment during seven study cycles. Women who have individual cycles that&#xD;
      do not meet the criteria for an evaluable cycle will not have those cycles replaced by&#xD;
      subsequent cycles in order to provide a total of seven evaluable cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">November 29, 2018</completion_date>
  <primary_completion_date type="Actual">November 29, 2018</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>Single Arm, unblinded</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy</measure>
    <time_frame>10 months</time_frame>
    <description>To evaluate the contraceptive efficacy of Amphora over 7-cycle of use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Adverse Events (AE)</measure>
    <time_frame>10 months</time_frame>
    <description>Incidence of AE to evaluate safety</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1384</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single-arm, open-label, Phase III study of AMPHORA , a non-hormonal contraceptive, at approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMPHORA</intervention_name>
    <description>non-hormonal contraceptive vaginal gel</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria:&#xD;
&#xD;
        To enroll in the clinical study, potential subjects must:&#xD;
&#xD;
          1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring&#xD;
             contraception.&#xD;
&#xD;
          2. Be within the age range of 18 to 35 years old (inclusive) at enrollment.&#xD;
&#xD;
          3. In the opinion of the Investigator, be at low risk for both human immunodeficiency&#xD;
             virus (HIV) and sexually transmitted infections (STIs) based on review of high-risk&#xD;
             behaviors and exposures according to the Centers for Disease Control STI Guideline.&#xD;
&#xD;
          4. At the time of enrollment, have a single male sex partner for ≥3 months.&#xD;
&#xD;
          5. Have a negative urine pregnancy test at enrollment.&#xD;
&#xD;
          6. Have normal, cyclic menses with a usual length of 21 to 35 days over the last two&#xD;
             cycles or at least two consecutive spontaneous menses (21 to 35 days in length) since&#xD;
             delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy&#xD;
             prior to the date of consent. In addition:&#xD;
&#xD;
               1. If the subject recently discontinued breastfeeding, she must have demonstrated&#xD;
                  return to regular cycling and have had at least three consecutive, spontaneous&#xD;
                  menses post-lactation prior to the date of consent.&#xD;
&#xD;
               2. If the subject received prior administration of injectable contraceptives (e.g.,&#xD;
                  depot-medroxyprogesterone acetate [DMPA], Depo Provera), there must be at least&#xD;
                  10 months since the last injection and the subject must have had at least two&#xD;
                  consecutive, spontaneous menses prior to the date of consent.&#xD;
&#xD;
               3. If a contraceptive implant was recently removed, the subject must have had at&#xD;
                  least two consecutive, spontaneous menses prior to the date of consent.&#xD;
&#xD;
               4. If an intrauterine device (IUD) was recently removed, the subject must have had&#xD;
                  at least one spontaneous menses following removal and prior to the date of&#xD;
                  consent.&#xD;
&#xD;
          7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per&#xD;
             cycle.&#xD;
&#xD;
          8. Be willing to use the study drug as the only method of contraception over the course&#xD;
             of the study (with the exception of emergency contraception [EC] in the event a&#xD;
             subject engages in vaginal intercourse but believes that the study drug was not used&#xD;
             properly or she is at risk for pregnancy for any other reason).&#xD;
&#xD;
          9. Be capable of using the study drug properly and agree to comply with all study&#xD;
             directions and requirements, including retaining the wrappers and returning them to&#xD;
             the clinical site at the next study visit.&#xD;
&#xD;
         10. Be willing to keep a daily electronic diary (eDiary) to record coital information,&#xD;
             study drug use information, use of concomitant medications including other vaginal&#xD;
             products and other contraceptives, menses, and sign and symptom data for the subject&#xD;
             or as reported to her by her partner.&#xD;
&#xD;
         11. Agree not to participate in any other clinical studies during the course of the study.&#xD;
&#xD;
         12. Be capable and willing to give written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        To enroll in the clinical study, potential subjects must not:&#xD;
&#xD;
          1. Have had three or more urinary tract infections (UTIs) in the past year from the date&#xD;
             of consent.&#xD;
&#xD;
          2. Have a UTI by urine culture, chlamydia, gonorrhea, or symptomatic yeast vaginitis or&#xD;
             symptomatic bacterial vaginosis (BV) diagnosed by wet mount, or trichomoniasis, unless&#xD;
             treated and proof of cure is documented within the screening period.&#xD;
&#xD;
          3. Have used vaginal or systemic antibiotics or antifungals within 14 days prior to&#xD;
             enrollment, with the exception of vaginal or systemic antibiotics or antifungals&#xD;
             completed for the treatment of a UTI, BV, or yeast vaginitis diagnosed at screening&#xD;
             within seven days of the Enrollment Visit.&#xD;
&#xD;
          4. Have a history of any recurrent vaginal infections/disorders (either greater than or&#xD;
             equal to four times in the past year or greater than or equal to three times in the&#xD;
             previous six months from the date of consent).&#xD;
&#xD;
          5. Be pregnant, have a suspected pregnancy, or desire to become pregnant during the&#xD;
             course of the study.&#xD;
&#xD;
          6. Have a history of diagnosed infertility or of conditions that may lead to infertility,&#xD;
             without subsequent non-assisted reproductive technology intrauterine pregnancy.&#xD;
&#xD;
          7. Have any maternal contraindications to pregnancy (medical condition) or chronic use of&#xD;
             medications for which significant evidence of fetal risk exists.&#xD;
&#xD;
          8. Have known or screen test positive for HIV infection.&#xD;
&#xD;
          9. Have three or more outbreaks of genital herpes simplex virus (HSV) within the last&#xD;
             year from the date of consent or be receiving suppressive therapy.&#xD;
&#xD;
         10. Have visible genital condylomata (warts).&#xD;
&#xD;
         11. Be lactating or breastfeeding.&#xD;
&#xD;
         12. Have any clinically significant abnormal finding on physical examination including&#xD;
             pelvic examination or baseline laboratory assessments which in the opinion of the&#xD;
             Investigator, precludes study participation.&#xD;
&#xD;
         13. Have clinically significant signs of vaginal or cervical irritation on pelvic&#xD;
             examination.&#xD;
&#xD;
         14. Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical&#xD;
             procedures during the period of the study.&#xD;
&#xD;
         15. Have an abnormal Papanicolaou test (Pap test) based on the following criteria:&#xD;
&#xD;
             a. Pap test in the past 12 months from the date of screening with atypical squamous&#xD;
             cells of undetermined significance (ASC-US) unless at least one of the following&#xD;
             criteria is met: i. Less than 21 years of age. ii. A repeat Pap test at least six&#xD;
             months later was normal. iii. Reflex human papillomavirus (HPV) testing was performed&#xD;
             and was negative for high-risk HPV.&#xD;
&#xD;
             iv. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring&#xD;
             treatment or treatment was performed and follow up at least six months after the&#xD;
             treatment showed no evidence of disease.&#xD;
&#xD;
             b. Pap test in the past 12 months from the date of screening with low grade squamous&#xD;
             intraepithelial lesion (LSIL) unless at least one of the following criteria is met: i.&#xD;
             Less than 21 years of age. ii. A colposcopy (with or without biopsy) found no evidence&#xD;
             of dysplasia requiring treatment or treatment was performed and follow up at least six&#xD;
             months after the treatment showed no evidence of disease.&#xD;
&#xD;
             c. Pap test in the past 12 months from the date of screening with atypical squamous&#xD;
             cells in which high grade squamous intraepithelial lesion cannot be excluded (ASC-H),&#xD;
             atypical glandular cells, high grade squamous intraepithelial lesion (HSIL), or ≥30&#xD;
             years old who are cytology negative and HPV 16- or HPV 18-positive unless colposcopy&#xD;
             and/or treatment was performed and follow up at least six months after the colposcopy&#xD;
             and/or treatment showed no evidence of disease.&#xD;
&#xD;
             d. Pap test in the past 12 months with malignant cells.&#xD;
&#xD;
         16. Consume (on average) more than three drinks of an alcoholic beverage per day.&#xD;
&#xD;
         17. In the opinion of the Investigator, have a history of substance abuse in the last 12&#xD;
             months.&#xD;
&#xD;
         18. Have taken an investigational drug or used an investigational device within the past&#xD;
             30 days from the date of consent.&#xD;
&#xD;
         19. In the opinion of the Investigator, have issues or concerns that may compromise the&#xD;
             safety of the subject, impact the subject's compliance with the protocol requirements,&#xD;
             or confound the reliability of the data acquired.&#xD;
&#xD;
         20. Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in&#xD;
             research activities, or their close relative.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Culwell</last_name>
    <role>Study Director</role>
    <affiliation>Evofem Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coastal Clinical Research, Inc.</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>East Valley Family Physicians 137</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Mesa Obstetricians &amp; Gynecologists 184</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85209</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Family Practice Specialists Ltd 170</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Trials AZ, LLC 176</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Radiant Research, Inc. 111</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Visions Clinical Research Tucson 138</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Eclipse Clinical Research 185</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Arkansas Primary Care Clinic 205</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72204</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC 135</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
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      <name>Essential Access Health 159</name>
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        <city>Berkeley</city>
        <state>California</state>
        <zip>94710</zip>
        <country>United States</country>
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      <name>Hope Clinical Research, LLC 163</name>
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        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Grossmont Center for Clinical Research 119</name>
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        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
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  <location>
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      <name>Northern California Research 179</name>
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        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
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      <name>Medical Center for Clinical Research 101</name>
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        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
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        <state>California</state>
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        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
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        <state>California</state>
        <zip>90502</zip>
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        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
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        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
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      <name>Downtown Women's Healthcare 109</name>
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        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
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      <name>Coastal Connecticut Research, LLC 141</name>
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        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
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      <name>Flordia Clinical Research Group, LLC 130</name>
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        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33759</zip>
        <country>United States</country>
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      <name>Clinical Physiology Associates 160</name>
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        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
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      <name>AGA Clinical Trials 108</name>
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        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
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        <state>Florida</state>
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        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
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  <location>
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      <name>UF Health Woman's Specialist - Emerson 194</name>
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        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
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        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
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      <name>Altus Research 142</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
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      <name>Optimal Research, LLC 107</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32934</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>South Florida Research Center, Inc. 165</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
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        <city>Miami</city>
        <state>Florida</state>
        <zip>33147</zip>
        <country>United States</country>
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        <state>Florida</state>
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        <country>United States</country>
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        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
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        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
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        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
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        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
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        <state>Florida</state>
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        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
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        <state>Georgia</state>
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        <country>United States</country>
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    <facility>
      <name>Elite Clinical Trials 105</name>
      <address>
        <city>Blackfoot</city>
        <state>Idaho</state>
        <zip>83221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Practice 132</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network, Inc. - Avon 144</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Advantage 162</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network, Inc. - Franklin 146</name>
      <address>
        <city>Franklin</city>
        <state>Indiana</state>
        <zip>46131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network, Inc. - Muncie 145</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC 131</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick OB/GYN 189</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc. 133</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saginaw Valley Medical Research Group, LLC 124</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood of the St. Louis Regions 169</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Edmond Pack, MD 192</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Nevada 136</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R. Garn Mabey, Jr., MD, Chartered 116</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bosque Women's Care 117</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates 114</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Cary 134</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Research 125</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Carolina Women's Center 103</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research 110</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Research Center 139</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radient Research, Inc. 152</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Research Network - Rapid Medical Research, Inc. 171</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv 128</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Healthcare for Women 151</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Philadelphia 186</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research South 126</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tennessee Medical Center 188</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Family Physicians 102</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78735</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions, Inc. 164</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine Associates of Texas 106</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice Research Organization 115</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brownstone Clinical Trials 191</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc. 182</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Texas Family Planning &amp; Cancer Screening 121</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Center for Drug Development. Inc. 150</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Family Medicine 104</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neera Bhatia, MD OB/GYN 180</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research 187</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physician's Research Options, LLC 178</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research 183</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PI-Coor Clinical Research, LLC 153</name>
      <address>
        <city>Centreville</city>
        <state>Virginia</state>
        <zip>20121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Tidewater 148</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 113</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>September 2020</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <results_first_submitted>June 2, 2020</results_first_submitted>
  <results_first_submitted_qc>July 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2020</results_first_posted>
  <disposition_first_submitted>November 19, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 7, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 22, 2020</disposition_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03243305/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03243305/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Interventional</title>
          <description>This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.&#xD;
AMPHORA: non-hormonal contraceptive vaginal gel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1384"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="449"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="935"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="170"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No sexually active</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study method no longer primary method</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Early terminations</title>
              <participants_list>
                <participants group_id="P1" count="267"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Interventional</title>
          <description>This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.&#xD;
AMPHORA: non-hormonal contraceptive vaginal gel</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1384"/>
          </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="27.7" spread="4.49"/>
                  </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="1384"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="571"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="805"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="348"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="955"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI) at Screening</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.770" spread="8.1079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy</title>
        <description>To evaluate the contraceptive efficacy of Amphora over 7-cycle of use</description>
        <time_frame>10 months</time_frame>
        <population>MITT population that included only those subjects whose diaries indicated that they used the study drug correctly for every act of intercourse for at least 1 menstrual cycle. Cycles in which the study drug was used incorrectly for 1 or more coital acts were removed, and the remaining cycles were aligned in order to provide contiguous cycles.</population>
        <group_list>
          <group group_id="O1">
            <title>Interventional</title>
            <description>This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.&#xD;
AMPHORA: non-hormonal contraceptive vaginal gel</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy</title>
          <description>To evaluate the contraceptive efficacy of Amphora over 7-cycle of use</description>
          <population>MITT population that included only those subjects whose diaries indicated that they used the study drug correctly for every act of intercourse for at least 1 menstrual cycle. Cycles in which the study drug was used incorrectly for 1 or more coital acts were removed, and the remaining cycles were aligned in order to provide contiguous cycles.</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="1182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Seven-cycle Pregnancy Percentage</param_type>
            <param_value>13.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.91</ci_lower_limit>
            <ci_upper_limit>17.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Adverse Events (AE)</title>
        <description>Incidence of AE to evaluate safety</description>
        <time_frame>10 months</time_frame>
        <population>All subjects enrolled into the study and who administered the study drug at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>Interventional</title>
            <description>This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.&#xD;
AMPHORA: non-hormonal contraceptive vaginal gel</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Adverse Events (AE)</title>
          <description>Incidence of AE to evaluate safety</description>
          <population>All subjects enrolled into the study and who administered the study drug at least once.</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="1330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with greater than or equal to 1 AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with greater than or equal to 1 SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to early discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of AEs: unlikely to be Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of AEs: possibly related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of AEs: probably related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of AEs: definitely related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship of AEs: not assessable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intensity of AEs: mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intensity of AEs: moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intensity of AEs: severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intensity of AEs: life-threatening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 months</time_frame>
      <desc>An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.</desc>
      <group_list>
        <group group_id="E1">
          <title>Interventional</title>
          <description>This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.&#xD;
AMPHORA: non-hormonal contraceptive vaginal gel</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Uterine rupture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hodgkin's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Premature separation of placenta</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Trisomy 21</sub_title>
                <description>Pregnancy-related SAEs that were reported after study completion</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Preeclampsia</sub_title>
                <description>Pregnancy-related SAEs that were reported after study completion</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Premature rupture of membrane</sub_title>
                <description>Pregnancy-related SAEs that were reported after study completion</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Non-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="601" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="266" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="1330"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="149" subjects_at_risk="1330"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Evofem, Inc.</organization>
      <phone>858 550 1900</phone>
      <email>kculwell@evofem.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/NCT03243305
org study id: AMP002
nct id: NCT03243305
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a single-arm, open-label, Phase III study in approximately 100 sites in the United
      States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of
      pregnancy.
Through assessments including pelvic examination, laboratory procedures, and medical and
      gynecological history, subjects will be screened for eligibility in order to enroll
      approximately 1349 subjects into the study. After a screening period of up to 60 days,
      enrolled women will receive study drug. Each woman will participate in the study until after
      she has completed treatment during seven study cycles. Women who have individual cycles that
      do not meet the criteria for an evaluable cycle will not have those cycles replaced by
      subsequent cycles in order to provide a total of seven evaluable cycles.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Arm, unblinded
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy
time frame: 10 months
description: To evaluate the contraceptive efficacy of Amphora over 7-cycle of use
measure: Number of Subjects With Adverse Events (AE)
time frame: 10 months
description: Incidence of AE to evaluate safety
arm group label: Interventional
arm group type: Experimental
description: This is a single-arm, open-label, Phase III study of AMPHORA , a non-hormonal contraceptive, at approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
intervention type: Drug
intervention name: AMPHORA
description: non-hormonal contraceptive vaginal gel
arm group label: Interventional
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Kelly Culwell
role: Study Director
affiliation: Evofem Inc.
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country: United States
responsible party type: Sponsor
sharing ipd: No
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