Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Female Orgasmic Disorder
Interventions
DRUG

Placebo

placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

DRUG

Low dose TBS-2

Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

DRUG

Medium dose TBS-2

Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

DRUG

High dose TBS-2

High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Trial Locations (53)

2031

Barbara Gross Research Unit, Randwick

3004

Monash University, Melbourne

5006

The Robinson Institute University of Adelaide, North Adelaide

6009

Keogh Institute for Medical Research, Nedlands

10032

Columbia University School of Nursing, New York

19114

Clinical Research of Philadelphia LLC, Philadelphia

21093

Maryland Center for Sexual Health, Lutherville

22903

University of Virginia Center for Psychiatric Clinical Research, Charlottesville

23114

Virginia Research Center, Midlothian

23502

Tidewater Physicians for Women, Norfolk

27612

Wake Research Associates LLC, Raleigh

30075

Atlanta North Gynecology, PC, Roswell

32207

University of Florida - Jacksonville, Jacksonville

32765

Compass Research East LLC, Oviedo

33134

Clinical Research of South Florida, Coral Gables

33401

Center for Marital and Sexual Health of South Florida, West Palm Beach

33761

Tampa Bay Medical Research Inc., Clearwater

33916

Clinical Physiology Associates, Fort Myers

35209

Radiant Research, Birmingham

35801

Medical Affiliated Research Center Inc., Huntsville

37203

Clinical Research Associates, Inc, Nashville

43213

Columbus Center for Women's Health Research, Columbus

44122

Center for Marital and Sexual Health Inc., Beachwood

44124

University Hospitals Case Medical Center, Mayfield Heights

44311

Radiant Research, Akron

45069

Cincinnati Urogynecology Associates (TRIHEALTH), West Chester

48025

QUEST Research Institute, Bingham Farms

55435

Radiant Research Inc., Edina

58103

Lillestol Research LLC, Fargo

59102

Montana Health Research Institute, Billings

60654

Radiant Research Inc., Chicago

61820

Women's Health Practice, Champaign

66202

Radiant Reseach, Overland Park

68510

Womens Clinic of Lincoln P.C., Lincoln

75231

Radiant Research Inc., Dallas

78229

Radiant Research Inc., San Antonio

San Antonio Psychiatric Research Center Dba Croft Group Research Center, San Antonio

78681

Texas Diabetes and Endocrinology, Round Rock

80218

Downtown Women's Health Care, Denver

80239

Radiant Research Inc., Denver

85224

Radiant Research Inc., Chandler

85712

Quality of Life Medical Research Center, Tucson

92108

Medical Center for Clinical Research, San Diego

92120

San Diego Sexual Medicine, San Diego

98105

Women's Clincial Research Center, Seattle

06340

Thameside OB/GYN Centre, Groton

06117

Greater Hartford Women's Health Associates, Hartford

T5A 4L8

Alta Clinical Research Inc., Edmonton

V3K 3P4

Gain Medical Centre, Coquitlam

V8T 5G4

Discovery Clinical Services, Ltd, Victoria

V8V 3N7

Victoria Clinical Research Inc, Victoria

R3A 1M3

Manitoba Clinic, Winnipeg

M9W 4L6

Manna Research, Toronto

All Listed Sponsors
lead

Acerus Pharmaceuticals Corporation

INDUSTRY