<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/NCT02210689</url>
  </required_header>
  <id_info>
    <org_study_id>13-1052</org_study_id>
    <nct_id>NCT02210689</nct_id>
  </id_info>
  <brief_title>A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actavis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Watson Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Actavis Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing&#xD;
      Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™,&#xD;
      Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the&#xD;
      treatment of bacterial vaginosis in non-pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study treatment period will be 1 day. Subject participation is 22-30 days. Expected study&#xD;
      duration is 10 to 12 months. The study will enroll in up to 30 clinical sites.&#xD;
&#xD;
      Test Product: One single-dose, pre-filled disposable applicator delivering approximately 5 g&#xD;
      of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson&#xD;
      Laboratories, Inc.)&#xD;
&#xD;
      Reference Product: One single-dose, pre-filled disposable applicator delivering approximately&#xD;
      5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal&#xD;
      cream 2% ) (Ther-Rx™)&#xD;
&#xD;
      Placebo Control: One single-dose, pre-filled disposable applicator delivering approximately 5&#xD;
      g of cream containing vehicle of the test product (Watson Laboratories, Inc.)&#xD;
&#xD;
      Dose and Mode A single applicator of investigational product cream will be administered of&#xD;
      Administration once intravaginally at any time of the day. The subject participation is 22-30&#xD;
      days (drug administration for 1 day).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score &lt;4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).</measure>
    <time_frame>22 to 30 days</time_frame>
    <description>Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:&#xD;
The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,&#xD;
The whiff test is negative for any amine (&quot;fishy&quot;) odor,&#xD;
The saline wet mount is negative for clue cells,&#xD;
Vaginal fluid pH is &lt; 4.7, using pH paper that measures from 3.6 to 6.1.&#xD;
A Bacteriological cure is defined as a Nugent score &lt; 4.&#xD;
The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:&#xD;
Lactobacillus: large gram positive rods,&#xD;
Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,&#xD;
Mobiluncus spp.: thin, curved Gram variable rods</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">604</enrollment>
  <condition>BACTERIAL VAGINOSIS</condition>
  <condition>Signs and Symptoms to be Evaluated and Recorded Include</condition>
  <condition>Vaginal Discharge Color, Odor, and Consistency</condition>
  <condition>Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe</condition>
  <condition>Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe</condition>
  <arm_group>
    <arm_group_label>test product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clindamycin phosphate vaginal cream 2%</intervention_name>
    <arm_group_label>reference product</arm_group_label>
    <arm_group_label>test product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>vehicle used as placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be willing and able to understand and comply with the requirements of&#xD;
             the protocol, including attendance at the required study visits and must provide the&#xD;
             written informed consent prior to any study related procedure being performed.&#xD;
&#xD;
          2. Healthy non-pregnant female aged ≥ 18 years with no known medical conditions that, in&#xD;
             the investigator's opinion, may interfere with study participation or may interfere&#xD;
             with the evaluation of bacterial vaginosis.&#xD;
&#xD;
          3. Female subjects of childbearing potential (excluding women who are surgically&#xD;
             sterilized or postmenopausal for at least 1 year), in addition to having a negative&#xD;
             urine pregnancy test must be willing to use an acceptable form of birth control during&#xD;
             the study from the day of the first dose administration to the Visit 2 Test-of-cure.&#xD;
             For the purpose of this study the following are considered acceptable methods of birth&#xD;
             control:&#xD;
&#xD;
               -  Oral or injectable contraceptives&#xD;
&#xD;
               -  Contraceptive patches&#xD;
&#xD;
               -  Depo-Provera® (stabilized for at least 3 months); Implanon™ (contraceptive&#xD;
                  implant), or abstinence with one of the above-listed methods of birth control&#xD;
                  should the Subject become sexually active.&#xD;
&#xD;
               -  A sterile sexual partner is NOT considered an adequate form of birth control.&#xD;
&#xD;
               -  Willing to refrain from sexual intercourse on study days 1-7 and for 48 hours&#xD;
                  prior to Visit 2 Test-of-cure.&#xD;
&#xD;
          4. Willing to refrain from using any vaginal product (e.g., spermicide, tampon, douche,&#xD;
             diaphragm, or condom) other than study product, on study Days 1-7, for 48 hours prior&#xD;
             to the first dose of study product, and for 48 hours prior to Visit 2 Test-of-cure.&#xD;
&#xD;
          5. Diagnosis of bacterial vaginosis, defined as the presence of all of the following:&#xD;
&#xD;
               -  Clinical diagnosis of bacterial vaginosis (e.g., thin, homogenous vaginal&#xD;
                  discharge associated with minimal or absent pruritus or inflammation AND&#xD;
&#xD;
               -  Saline wet mount of vaginal discharge demonstrating the proportion of clue cell&#xD;
                  to be ≥ 20% of the total epithelial cells AND&#xD;
&#xD;
               -  Vaginal pH &gt; 4.5, using pH paper that measures from 4.0-6.0 AND&#xD;
&#xD;
               -  Positive &quot;whiff test&quot; after addition of a drop of 10% KOH to vaginal discharge)&#xD;
&#xD;
               -  Gram stain Nugent score ≥ 4 on first day of dosing (study day 1) (per Table 1&#xD;
                  below).&#xD;
&#xD;
               -  Table 1: Nugent Scoring System (0-10) for Gram-stained Vaginal Smears (a)&#xD;
&#xD;
               -  Score (b) Lactobacillus morphotypes Gardnerella and Bacteroides spp. morphotypes&#xD;
                  Curved gram-variable rods&#xD;
&#xD;
               -  0 4+ 0 0&#xD;
&#xD;
               -  1 3+ 1+ 1+ or 2+&#xD;
&#xD;
               -  2 2+ 2+ 3+ or 4+&#xD;
&#xD;
               -  3 1+ 3+&#xD;
&#xD;
               -  4 0 4+&#xD;
&#xD;
        Source: Nugent, R. P., M. A. Krohn, and S. L. Hillier. Reliability of diagnosing bacterial&#xD;
        vaginosis is improved by a standardized method of Gram stain interpretation. J. Clin.&#xD;
        Microbial. 1991; 29: 297-301.&#xD;
&#xD;
          -  Morphotypes are scored as the average number seen per oil immersion field. Note that&#xD;
             less weight is given to curved gram-variable rods. Total score = lactobacilli + G.&#xD;
             vaginalis and Bacteroides spp/ + curved rods.&#xD;
&#xD;
          -  0, No morphotypes present; 1, &lt;1 morphotype present; 2, 1 to 4 morphotypes present; 3,&#xD;
             5 to 30 morphotypes present; 4, 30 or more morphotypes present.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant, nursing or planning to become pregnant during study&#xD;
             participation.&#xD;
&#xD;
          2. Menstruating when diagnosis of bacterial vaginosis is determined at Baseline visit.&#xD;
&#xD;
          3. Primary or secondary immunodeficiency.&#xD;
&#xD;
          4. Severe liver disease.&#xD;
&#xD;
          5. History of regional enteritis, ulcerative colitis, or a history of&#xD;
             &quot;antibiotic-associated&quot; colitis.&#xD;
&#xD;
          6. Evidence of any vulvovaginitis other than bacterial vaginosis. (e.g., candidiasis,&#xD;
             Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex).&#xD;
&#xD;
          7. Subjects with visible signs of HPV infection, i.e. visible warts.&#xD;
&#xD;
          8. Subject with another vaginal or vulvar condition, which would confound the&#xD;
             interpretation of clinical response.&#xD;
&#xD;
          9. Subject will be under treatment during the study period for cervical intraepithelial&#xD;
             neoplasia (CIN) or cervical carcinoma.&#xD;
&#xD;
         10. History of hypersensitivity to clindamycin, lincomycin, or any of the components of&#xD;
             the vaginal creams.&#xD;
&#xD;
         11. Use within 2 weeks prior to baseline of 1) topical or systemic antibiotics or 2)&#xD;
             topical or systemic antifungal.&#xD;
&#xD;
         12. Use of spermicides, tampons, douches, diaphragms, condoms within 48 hours of the&#xD;
             baseline visit.&#xD;
&#xD;
         13. Concurrent use of systemic corticosteroids or systemic antibiotics.&#xD;
&#xD;
         14. Unwilling or unable to comply with the protocol requirements.&#xD;
&#xD;
         15. Subjects who have participated in an investigational drug study (i.e., subjects have&#xD;
             been treated with an investigational drug) within 30 days prior to baseline will be&#xD;
             excluded from study participation. Subjects who are participating in non-treatment&#xD;
             studies such as observational studies or registry studies can be considered for&#xD;
             inclusion.&#xD;
&#xD;
         16. Subjects who have been previously enrolled in this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nageshwar r thudi, Ph.D., CCRP</last_name>
    <role>Study Director</role>
    <affiliation>Actavis Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akesis Investigator site 5</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 12</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 6</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 1</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 14</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 17</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 8</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 10</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 9</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 15</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 16</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 11</name>
      <address>
        <city>Port Jefferson</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 13</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 7</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 18</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 3</name>
      <address>
        <city>Santo Domingo</city>
        <state>Republica Dominicana</state>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis investigator site 4</name>
      <address>
        <city>Santo Domingo</city>
        <state>Republica Dominicana</state>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akesis Investigator site 2</name>
      <address>
        <city>Ponce</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>December 11, 2019</results_first_submitted>
  <results_first_submitted_qc>December 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 26, 2019</results_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
    <mesh_term>Vaginal Discharge</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The populations for this study included the Safety Population, the Per-Protocol (PP) Population, and the Modified Intent-to-treat (mITT) Population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Generic Clindamycin Phosphate Vaginal Cream 2%</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="P2">
          <title>Clindesse (Clindamycin Phosphate Vaginal Cream 2%)</title>
          <description>One single-dose, pre-filled, disposable applicator of Investigational product to be administered intravaginally at home.</description>
        </group>
        <group group_id="P3">
          <title>Vehicle Cream</title>
          <description>One single-dose, pre-filled, disposable applicator of Investigational product was to be inserted intravaginally at home.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="242"/>
                <participants group_id="P2" count="240"/>
                <participants group_id="P3" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="236"/>
                <participants group_id="P3" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>mITT Population</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="207"/>
                <participants group_id="P3" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PP Population</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="169"/>
                <participants group_id="P3" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
                <participants group_id="P2" count="193"/>
                <participants group_id="P3" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Prohibited medication</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Negative Nugent score at baseline</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who received the study drug (Safety Population)</population>
      <group_list>
        <group group_id="B1">
          <title>Generic Clindamycin Phosphate Vaginal Cream 2%</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="B2">
          <title>Clindesse (Clindamycin Phosphate Vaginal Cream 2%)</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="B3">
          <title>Vehicle Cream</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="233"/>
            <count group_id="B2" value="236"/>
            <count group_id="B3" value="122"/>
            <count group_id="B4" value="591"/>
          </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="34.5" spread="9.66"/>
                    <measurement group_id="B2" value="35.8" spread="10.2"/>
                    <measurement group_id="B3" value="35.1" spread="10.17"/>
                    <measurement group_id="B4" value="35.1" spread="9.98"/>
                  </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="233"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="122"/>
                    <measurement group_id="B4" value="591"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_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="45"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="187"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="471"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="304"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="233"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="122"/>
                    <measurement group_id="B4" value="591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score &lt;4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).</title>
        <description>Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:&#xD;
The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,&#xD;
The whiff test is negative for any amine (&quot;fishy&quot;) odor,&#xD;
The saline wet mount is negative for clue cells,&#xD;
Vaginal fluid pH is &lt; 4.7, using pH paper that measures from 3.6 to 6.1.&#xD;
A Bacteriological cure is defined as a Nugent score &lt; 4.&#xD;
The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:&#xD;
Lactobacillus: large gram positive rods,&#xD;
Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,&#xD;
Mobiluncus spp.: thin, curved Gram variable rods</description>
        <time_frame>22 to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)&#xD;
clindamycin phosphate vaginal cream 2%</description>
          </group>
          <group group_id="O2">
            <title>Reference Product</title>
            <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)&#xD;
clindamycin phosphate vaginal cream 2%</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)&#xD;
placebo: vehicle used as placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score &lt;4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).</title>
          <description>Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:&#xD;
The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,&#xD;
The whiff test is negative for any amine (&quot;fishy&quot;) odor,&#xD;
The saline wet mount is negative for clue cells,&#xD;
Vaginal fluid pH is &lt; 4.7, using pH paper that measures from 3.6 to 6.1.&#xD;
A Bacteriological cure is defined as a Nugent score &lt; 4.&#xD;
The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:&#xD;
Lactobacillus: large gram positive rods,&#xD;
Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,&#xD;
Mobiluncus spp.: thin, curved Gram variable rods</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 30 days</time_frame>
      <desc>Adverse events were collected from participants who were randomized and received the study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Generic Clindamycin Phosphate Vaginal Cream 2%</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="E2">
          <title>Clindesse (Clindamycin Phosphate Vaginal Cream 2%)</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
        <group group_id="E3">
          <title>Vehicle Cream</title>
          <description>One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Eye Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </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="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Neoplams benign, malignant and unspecified</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Uterine spasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vaginal odour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Vulvovaginal swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="236"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="122"/>
              </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 results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director, CE Studies</name_or_title>
      <organization>Teva Pharmaceuticals USA. Inc.</organization>
      <phone>1-888-483-8279</phone>
      <email>USMedInfo@tevapharm.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/NCT02210689
org study id: 13-1052
nct id: NCT02210689
lead sponsor: 
collaborator: 
has dmc: No
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing
      Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™,
      Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the
      treatment of bacterial vaginosis in non-pregnant women.
The study treatment period will be 1 day. Subject participation is 22-30 days. Expected study
      duration is 10 to 12 months. The study will enroll in up to 30 clinical sites.

      Test Product: One single-dose, pre-filled disposable applicator delivering approximately 5 g
      of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson
      Laboratories, Inc.)

      Reference Product: One single-dose, pre-filled disposable applicator delivering approximately
      5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal
      cream 2% ) (Ther-Rx™)

      Placebo Control: One single-dose, pre-filled disposable applicator delivering approximately 5
      g of cream containing vehicle of the test product (Watson Laboratories, Inc.)

      Dose and Mode A single applicator of investigational product cream will be administered of
      Administration once intravaginally at any time of the day. The subject participation is 22-30
      days (drug administration for 1 day).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).
time frame: 22 to 30 days
description: Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:
The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,
The whiff test is negative for any amine ("fishy") odor,
The saline wet mount is negative for clue cells,
Vaginal fluid pH is < 4.7, using pH paper that measures from 3.6 to 6.1.
A Bacteriological cure is defined as a Nugent score < 4.
The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:
Lactobacillus: large gram positive rods,
Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,
Mobiluncus spp.: thin, curved Gram variable rods
arm group label: test product
arm group type: Experimental
description: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)
arm group label: reference product
arm group type: Active Comparator
description: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)
arm group label: placebo
arm group type: Placebo Comparator
description: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)
intervention type: Drug
intervention name: clindamycin phosphate vaginal cream 2%
arm group label: reference product
arm group label: test product
intervention type: Other
intervention name: placebo
description: vehicle used as placebo
arm group label: placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: nageshwar r thudi, Ph.D., CCRP
role: Study Director
affiliation: Actavis Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Dominican Republic
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Vaginal Discharge
mesh term: Inflammation
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 