NCT03294538

Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 663 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the marketed product, Estrace® Cream estradiol vaginal cream USP, 0.01% (Warner Chilcott) in participants with atrophic vaginitis; to demonstrate the superiority of the Test and Reference (active) treatments over Placebo (vehicle) cream in participants with atrophic vaginitis; and to compare the safety of Test, Reference, and Placebo treatments in participants with atrophic vaginitis.

Detailed description

Systemic (oral or transdermal patch administration) estrogen therapies have been shown to effectively treat symptoms of atrophic vaginitis but bear undesirable side effects including increased risk of heart attacks, stroke, endometrial cancer, and breast cancer. Topical therapies (creams and transvaginal delivery systems) provide low doses of estrogen to the vaginal mucosa to provide local relief for the symptoms of atrophic vaginitis, while reducing the unwanted side effects associated with systemic delivery systems. Low dose, topical estrogen therapy is considered most appropriate and convenient for the treatment of vaginal symptoms associated with menopause, particularly when other symptoms including bone loss or vasomotor dysfunction do not need to be targeted.

Conditions

• Atrophic Vaginitis

Interventions

Type	Name	Description
DRUG	Generic Estradiol Vaginal Cream USP, 0.01%	Vaginal cream, generic formulation of the brand product.
DRUG	Estrace® Vaginal Cream USP, 0.01%	Vaginal cream, brand product.
DRUG	Vehicle Vaginal Cream	Vaginal cream, placebo. Has no active ingredient

Timeline

• Start date: 2016-05-18
• Primary completion: 2017-02-15
• Completion: 2017-02-15
• First posted: 2017-09-27
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study