A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

Summary

The purpose of this study is to determine the therapeutic equivalence of Mylan'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.

Conditions

• Atrophic Vaginitis

Interventions

DRUG

Estradiol Vaginal Cream, 0.01%

Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)

DRUG

Estrace® 0.01% cream

Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)

DRUG

Placebo Vaginal Cream

Placebo Vaginal Cream ( 1 x 2 g for 7 days)

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc

  lead INDUSTRY

Principal Investigators

• Matt Hummel, Ph.D. · Mylan Pharmaceuticals Inc

• Ronald Ackerman, M.D. · Comprehensive Clinical Trials, LLC

• James Andersen, M.D. · Meridien Research

• Keith Aqua, M.D. · Visions Clinical Research

• Theodore Cooper, M.D. · Horizons Clinical Research Center, LLC

• Scott Eder, M.D. · Women's Health Research Center/The Center for Women's Health & Wellness, LLC

• William Koltun, M.D. · Medical Center for Clinical Research

• Gigi Lefebvre, M.D. · Meridien Research

• Leonard Ranasinghe, M.D. · Northern CA Research

• Rovena Reagan, M.D. · Women's Health Care Research Corp.

• Ronald Surowitz, D.O. · Health Awareness, Inc.

• Steven Sussman, M.D. · Lawrence OB/GYN Clinical Research, LLC

• G. Michael Swor, M.D. · Physician Care Clinical Research LLC

• Olga Tudela, M.D. · Veritas Research., Corp.

• Arthur Waldbaum, M.D. · Downtown Women's Health Care

• Maria C Fernandez, M.D. · South Coast Research Center, Inc.

• Gary Carson, M.D · Northern CA Research

• Lydie Hazan, M.D. · Axis Clinical Trials

• Alfred Moffett, M.D. · OB-GYN Associates of Mid Florida

• Tracey Lemon, M.D. · Georgia Center for Women

• Steven Foley, M.D. · MCB Clinical Research Centers, LLC

• Jason Haffizulla, M.D. · Sunrise Medical Research, Inc.

• Robert Hunter, M.D. · ARA-Arizona Research Associates

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United States

Study Locations