NCT02210689

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	clindamycin phosphate vaginal cream 2%
OTHER	placebo	vehicle used as placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-08-07
• Last updated: 2020-01-28
• Results posted: 2019-12-26

Locations

18 sites across 3 countries: United States, Dominican Republic, Puerto Rico