Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

PHASE3CompletedINTERVENTIONAL
Enrollment

519

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

September 30, 2012

Study Completion Date

December 31, 2012

Conditions
Atrophic Vaginitis Due to Menopause
Interventions
DRUG

Estradiol Vaginal Tablets 10 mcg

DRUG

placebo

Trial Locations (25)

12601

Premier Medical Group of the Hudson Valley, Poughkeepsie

19114

Clinical Research of Philadelphia, LLC, Philadelphia

20036

James A. Simon, MD PC/ Women's Health and Research Consultants, Washington D.C.

27103

Hawthorne Medical Research, Inc., Winstom-Salem

Lyndhurst Clinical Research, Winston-Salem

27607

Lyndhurst Clinical Research, Raleigh

27612

Wake Research Associates, Raleigh

30075

Atlanta North Gynecology, Roswell

30328

Mount Vernon Clinical Research, LLC, Sandy Springs

32216

Jacksonville Center for Clinical Research, Jacksonville

33186

New Age Medical Reserach Group, Miami

33409

Comprehensive Clinical Trials, LLC, West Palm Beach

33461

Altus Research, Lake Worth

33472

Visions Clinical Reserach, Boynton Beach

35801

Medical Affiliated Research center, Inc., Huntsville

36117

Montogmery Women's Health Associates, Montgomery

43213

Columbus Center for Women;s Health Reserach, Columbus

67226

Cypress Medical Research Center. LLC, Wichita

80218

Downtown Women's Health care, Denver

80220

Horizons Clinical Research Center, Denver

92108

Medical Center for Clinical Research, San Diego

92123

Women's Health Care Research Corp., San Diego

98105

Seatlle Womne's Health,Reserach, Gynecology, Seattle

07753

Meridian Health Care, Neptune City

08536

Center for Women's Health and Wellness, LLC/ Women's Health Research Center, Plainsboro

Sponsors
All Listed Sponsors
lead

Amneal Pharmaceuticals, LLC

INDUSTRY