Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

PHASE3CompletedINTERVENTIONAL
Enrollment

722

Participants

Timeline

Start Date

June 29, 2011

Primary Completion Date

February 27, 2012

Study Completion Date

February 27, 2012

Conditions
Postmenopausal Vulvovaginal Atrophy
Interventions
DRUG

WC3011 Estradiol Vaginal Cream

WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks

DRUG

Vehicle

Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Trial Locations (70)

15090

Susan L. Floyd, MD, PC, Wexford

15206

Clinical Trials Research Services, LLC, Pittsburgh

19046

The Clinical Trial Center, LLC, Jenkintown

19114

Philadelphia Clinical Research, LLC, Philadelphia

23233

Virginia Women's Center, Richmond

27103

Hawthorne Medical Research, Inc., Winston-Salem

Lyndhurst Clinical Research, Winston-Salem

27408

Hawthorne Medical Research, Inc., Greensboro

27612

Wake Research Associates, LLC, Raleigh

28562

Eastern Carolina Women's Center, New Bern

29201

SC Clinical Research Center, LLC, Columbia

29910

Fellows Research Alliance, Inc., Bluffton

30034

Soapstone Center for Clinical Research, Decatur

30075

Atlanta North Gynecology, PC, Roswell

30342

Radiant Research-Atlanta, Atlanta

31406

Fellows Research Alliance, Inc., Savannah

32174

Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach

32216

Jacksonville Center for Clinical Research, Jacksonville

33143

Miami Research Associates, Miami

33186

New Age Medical Research Corp, Miami

33409

Comprehensive Clinical Trials, LLC, West Palm Beach

33410

OB-GYN Specialists of the Palm, Palm Beach Gardens

33472

Visions Clinical Research, Boynton Beach

33759

Women's Medical Research Group, LLC, Clearwater

33781

Radiant Research-St. Petersburg, Pinellas Park

35801

Medical Affiliated Research Center, Inc., Huntsville

36608

Mobile OB-GYN, PC, Mobile

40004

Kentucky Pediatric Research, Inc., Bardstown

40291

Bluegrass Clinical Research, Inc., Louisville

43213

The Columbus Center for Women's Health Research, Columbus

44122

Rapid Medical Research, Inc., Cleveland

45322

HWC - Women's Research Center, Englewood

46530

The South Bend Clinic, LLP, Granger

49009

Beyer Research, Kalamazoo

55318

Ridgeview Research Two Twelve Medical Center, Chaska

60654

Radiant Research-Chicago, Chicago

62703

Springfield Clinical, LLP, Springfield

66202

Radiant Research - Overland Park, Overland Park

67207

Heartland Research Associates, Wichita

70072

York Clinical Consulting, Marrero

70115

Women Under Study, New Orleans

75230

Practice Research Organization, Inc., Dallas

75231

Radiant Research-Dallas, Dallas

75234

Research Across America RHD Professional Plaza 4, Dallas

77030

Advances in Health, Inc., Houston

77598

Center for Reproductive Medicine, Webster

78229

Radiant Research-San Antonio, San Antonio

80228

Physicians' Research Options LLC, Lakewood

84070

Physicians' Research Options LLC, Sandy City

84109

J. Lewis Research-foothill Family Clinic, Salt Lake City

84121

J. Lewis Research - Foothill Family Clinic South, Salt Lake City

85015

Women's Health Research, Phoenix

85032

Precision Trials, LLC, Phoenix

85251

Radiant Research-Scottsdale, Scottsdale

85710

Radiant Research-Tucson, Tucson

85712

Visions Clinical Research-tucson, Tucson

89106

Affiliated Clinical Research, Las Vegas

92103

Genesis Center for Clinical Research, San Diego

92108

Medical Center for Clinical Research, San Diego

92123

Women's Healthcare Inc., San Diego

97401

Clinical Trials of America, Inc., Eugene

97504

Advanced Clinical Research, Medford

98105

Seattle Women's: Health, Research Gynecology, Seattle

99207

North Spokane Women's Clinic, Spokane

06320

Costal Connecticut Resarch, LLC, New London

08648

Lawrence OB-GYN Associates, P.C., Lawrenceville

08051

Phoenix OB-GYN Assoc., LLC, Moorestown

08536

The Center for Women's Health and Wellness, LLC, Plainsboro

02886

Omega Medical Research, Warwick

23507-1627

Eastern Virginia Medical School, Norfolk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT01400776 - Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women | Biotech Hunter | Biotech Hunter