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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 Treatmen

2015-04-14 10:27:23 | BioPortfolio

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.

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

BACTERIAL VAGINOSIS

Intervention

clindamycin phosphate vaginal cream 2%

Location

Akesis Investigator site 5
Birmingham
Alabama
United States
32771

Status

Completed

Source

Actavis Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-14T10:27:23-0400

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