NCT02995694

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 535 (actual)
• Sponsor: Alvogen Pine Brook LLC · Industry
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Detailed description

This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo. Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment. Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows: * Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) * Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott) * Placebo: Test product vehicle cream (Alvogen Pine Brook LLC) Patients completed up to three clinic visits as follows: * Visit 1 - Screening: Day -14 to Day -1 * Visit 2 - Randomization: Day 1 * Visit 3 - End of Study: Day 8, maximum Day 10 Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.

Conditions

• Atrophic Vaginitis

Interventions

Type	Name	Description
DRUG	Estradiol	Estradiol Vaginal Cream
DRUG	Placebos	Placebo with no active pharmaceutical ingredients. Topical vaginal cream
DRUG	Reference	Estrace Vaginal Cream

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-12-16
• Last updated: 2021-12-01
• Results posted: 2021-12-01