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

BACTERIAL VAGINOSIS Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• BACTERIAL VAGINOSIS
• Inflammation
• Signs and Symptoms
• Signs and Symptoms to be Evaluated and Recorded Include
• Vaginal Discharge
• Vaginal Discharge Color, Odor, and Consistency
• Vaginal Diseases
• Vaginosis, Bacterial
• Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe
• Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe

• NCT number: NCT02210689
• Study type: Interventional
• Source: Actavis Inc.
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Completion date: December 2014