A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

PHASE2CompletedINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

February 15, 2016

Primary Completion Date

November 14, 2016

Study Completion Date

November 14, 2016

Conditions
Vulvovaginal AtrophyMenopauseDyspareunia
Interventions
DRUG

Estradiol Vaginal Capsule (EVC)

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

DRUG

Placebo

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Trial Locations (20)

19114

Clinical Research of Philadelphia, LLC, Philadelphia

23233

Virginia Women's Center, Richmond

27103

Hawthorne Medical Research, Inc., Winston-Salem

27713

Carolina Women's Research and Wellness Center, Durham

29910

Fellows Research Alliance, Inc, Bluffton

31406

Fellows Research Alliance, Inc, Savannah

33409

Comprehensive Clinical Trials, LLC, West Palm Beach

33759

Women's Medical Research Group, LLC, Clearwater

33781

Radiant Research, Inc., Pinellas Park

43213

Women's Health Research, Columbus

44122

Rapid Medical Research, Inc., Cleveland

49009

Beyer Research, Kalamazoo

75231

Radiant Research, Inc., Dallas

78229

Radiant Research, Inc., San Antonio

85712

Visions Clinical Research-Tucson, Tucson

89128

Office of R. Garn Mabey, M.D., Las Vegas

92103

Genesis Center for Clinical Research, San Diego

98105

Seattle Women's Health, Research, Gynecology, Seattle

99207

North Spokane Women's Clinic, Spokane

06320

Coastal Connecticut Research, LLC, New London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT02670785 - A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy | Biotech Hunter | Biotech Hunter