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
Condition: BACTERIAL VAGINOSIS; Signs and Symptoms to be Evaluated and Recorded Include; Vaginal Discharge Color, Odor, and Consistency; Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe; Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Vaginal Discharge; Inflammation
Intervention: clindamycin phosphate vaginal cream 2%; placebo
Intervention description: vehicle used as placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 604.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be willing and able to understand and comply with the requirements of
             the protocol, including attendance at the required study visits and must provide the
             written informed consent prior to any study related procedure being performed.

          2. Healthy non-pregnant female aged ≥ 18 years with no known medical conditions that, in
             the investigator's opinion, may interfere with study participation or may interfere
             with the evaluation of bacterial vaginosis.

          3. Female subjects of childbearing potential (excluding women who are surgically
             sterilized or postmenopausal for at least 1 year), in addition to having a negative
             urine pregnancy test must be willing to use an acceptable form of birth control during
             the study from the day of the first dose administration to the Visit 2 Test-of-cure.
             For the purpose of this study the following are considered acceptable methods of birth
             control:

               -  Oral or injectable contraceptives

               -  Contraceptive patches

               -  Depo-Provera® (stabilized for at least 3 months); Implanon™ (contraceptive
                  implant), or abstinence with one of the above-listed methods of birth control
                  should the Subject become sexually active.

               -  A sterile sexual partner is NOT considered an adequate form of birth control.

               -  Willing to refrain from sexual intercourse on study days 1-7 and for 48 hours
                  prior to Visit 2 Test-of-cure.

          4. Willing to refrain from using any vaginal product (e.g., spermicide, tampon, douche,
             diaphragm, or condom) other than study product, on study Days 1-7, for 48 hours prior
             to the first dose of study product, and for 48 hours prior to Visit 2 Test-of-cure.

          5. Diagnosis of bacterial vaginosis, defined as the presence of all of the following:

               -  Clinical diagnosis of bacterial vaginosis (e.g., thin, homogenous vaginal
                  discharge associated with minimal or absent pruritus or inflammation AND

               -  Saline wet mount of vaginal discharge demonstrating the proportion of clue cell
                  to be ≥ 20% of the total epithelial cells AND

               -  Vaginal pH > 4.5, using pH paper that measures from 4.0-6.0 AND

               -  Positive "whiff test" after addition of a drop of 10% KOH to vaginal discharge)

               -  Gram stain Nugent score ≥ 4 on first day of dosing (study day 1) (per Table 1
                  below).

               -  Table 1: Nugent Scoring System (0-10) for Gram-stained Vaginal Smears (a)

               -  Score (b) Lactobacillus morphotypes Gardnerella and Bacteroides spp. morphotypes
                  Curved gram-variable rods

               -  0 4+ 0 0

               -  1 3+ 1+ 1+ or 2+

               -  2 2+ 2+ 3+ or 4+

               -  3 1+ 3+

               -  4 0 4+

        Source: Nugent, R. P., M. A. Krohn, and S. L. Hillier. Reliability of diagnosing bacterial
        vaginosis is improved by a standardized method of Gram stain interpretation. J. Clin.
        Microbial. 1991; 29: 297-301.

          -  Morphotypes are scored as the average number seen per oil immersion field. Note that
             less weight is given to curved gram-variable rods. Total score = lactobacilli + G.
             vaginalis and Bacteroides spp/ + curved rods.

          -  0, No morphotypes present; 1, <1 morphotype present; 2, 1 to 4 morphotypes present; 3,
             5 to 30 morphotypes present; 4, 30 or more morphotypes present.

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing or planning to become pregnant during study
             participation.

          2. Menstruating when diagnosis of bacterial vaginosis is determined at Baseline visit.

          3. Primary or secondary immunodeficiency.

          4. Severe liver disease.

          5. History of regional enteritis, ulcerative colitis, or a history of
             "antibiotic-associated" colitis.

          6. Evidence of any vulvovaginitis other than bacterial vaginosis. (e.g., candidiasis,
             Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex).

          7. Subjects with visible signs of HPV infection, i.e. visible warts.

          8. Subject with another vaginal or vulvar condition, which would confound the
             interpretation of clinical response.

          9. Subject will be under treatment during the study period for cervical intraepithelial
             neoplasia (CIN) or cervical carcinoma.

         10. History of hypersensitivity to clindamycin, lincomycin, or any of the components of
             the vaginal creams.

         11. Use within 2 weeks prior to baseline of 1) topical or systemic antibiotics or 2)
             topical or systemic antifungal.

         12. Use of spermicides, tampons, douches, diaphragms, condoms within 48 hours of the
             baseline visit.

         13. Concurrent use of systemic corticosteroids or systemic antibiotics.

         14. Unwilling or unable to comply with the protocol requirements.

         15. Subjects who have participated in an investigational drug study (i.e., subjects have
             been treated with an investigational drug) within 30 days prior to baseline will be
             excluded from study participation. Subjects who are participating in non-treatment
             studies such as observational studies or registry studies can be considered for
             inclusion.

         16. Subjects who have been previously enrolled in this study.