Conditions: 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 604
Healthy volunteers: no

Brief 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.

Detailed description:
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).

Arms:
arm 1: 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 2: 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 3: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)

Interventions: intervention 1: clindamycin phosphate vaginal cream 2% intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: vehicle used as placebo

Protocol document: