Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

PHASE3CompletedINTERVENTIONAL
Enrollment

3,389

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Contraception
Interventions
DRUG

Conceptrol

• Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

DRUG

Amphora

• Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Trial Locations (52)

10016

NYU Medical Center Family Planning, New York

10032

Columbia University Medical Center, Division of Family Planning, New York

15213

Magee-Womens Hospital, Pittsburgh

19104

University of Pennsylvania Medical Center, Reproductive Research Unit, Philadelphia

19114

Philadelphia Clinical Research, Philadelphia

21211

Johns Hopkins Community Physicians, Baltimore

27612

Wake Research Associates, Raleigh

28562

Eastern Carolina Women's Center, New Bern

30034

Soapstone Center for Clinical Research, Decatur

32720

Avail Clinical Reseach, DeLand

33143

Miami Research Associates, Miami

33161

Segal Institute for Clinical Research, North Miami

33409

Comprehensive Clinical Trials, West Palm Beach

33461

Altus Research, Lake Worth

33709

Meridien Research, St. Petersburg

34208

Meridien Research, Bradenton

35235

Alabama Clinical Therapeutics, LLC, Birmingham

44302

Planned Parenthood of Northeast Ohio, Cleveland

45267

University of Cincinnati, Cincinnati

61820

Downtown Women's Healthcare, Denver

67207

Heartland Research Associates, LLC, Wichita

72205

Lynn Institute of the Ozarks, Little Rock

75062

MacArthur OB/GYN, Irving

75230

Practice Research Organization, Dallas

75390

UT Southwestern Medical Center - Dept. of OB/GYN, Dallas

77054

TMC Life Research, Inc, Houston

78414

Advanced Research Associates, Corpus Christi

80302

Planned Parenthood of the Rocky Mountains, Denver

83404

Rosemark WomenCare Specialist, Idaho Falls

84124

Jean Brown Research, Salt Lake City

89106

Impact Clinical Trials, Las Vegas

90010

California Family and Health Council, Inc., LA, Los Angeles

California Family Health Council, Los Angeles

92123

Women's Health Care, San Diego

92801

Advanced Clinical Research Institute, Anaheim

Anaheim Clinical Trials, LLC, Anaheim

94710

California Family Health Council, Inc., Berkeley

97239

Oregon Health Sciences University, Portland

98105

Women's Clinical Research Center, Seattle

101000

Moscow Regional Research Institute of Obstetrics and Gynecology, Moscow

115280

City Clinical Hospital #13, Moscow

119415

City Clinical Hospital #31, Moscow

119991

First Moscow State Medical University named after IM Sechenov, Moscow

195257

Maternity Hospital #17, Saint Petersburg

197374

"Medical Center Prime-RoseLLC", Saint Petersburg

199034

The DO Ott Research Institute of Obstetrics and Gynecology, Saint Petersburg

199178

Hospital OrCli, Saint Petersburg

344068

"State Budgetary Institution fo Rostov region Parinatal Center", Rostov-on-Don

420012

Kazan State Medical University, Kazan'

620028

Ural Scientific Research Institution of Maternity and Child Protection, Yekaterinburg

06095

Stamford Therapeutics Consortium, Stamford

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Premier Research

OTHER

lead

Evofem Inc.

INDUSTRY