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

Phase 2

Completed

Conditions: Female Orgasmic Disorder

Interventions: Drug: Placebo
Drug: High dose TBS-2
Drug: Medium dose TBS-2
Drug: Low dose TBS-2

Registration Number: NCT01607658

Lead Sponsor: Acerus Pharmaceuticals Corporation

Brief Summary: The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
Experimental 3	High dose TBS-2	High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn
Experimental 2	Medium dose TBS-2	Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn
Experimental 1	Low dose TBS-2	Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn

Primary Outcome Measures

Name	Time	Method
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period	84 days

Secondary Outcome Measures

Name	Time	Method
Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84	Day 0 and Day 84	as measured by Female Sexual Distress Scale (FSDS-DAO) Question #15 on Day 0 and 84, respectively. Question #15 evaluates the level of distress related to problems with orgasm. It is rated on a 5-point Likert scale (from 0 to 4, i.e. never \[0\], rarely \[1\], occasionally \[2\], frequently \[3\], or always \[4\]). Higher scores indicate more distress.
Change in Global Sexual Functioning From Day 0 to Day 84	Day 0 and Day 84	as measured by Female Sexual Function Index (FSFI) on Day 0 and 84, respectively. The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual frustration in women. The questionnaire provides scores on 6 domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. Fifteen items are rated on a 6-point Likert scale (from 0 to 5) and 4 items on a 5-point Likert scale (from 1 to 5). The scores are added and converted using a conversion factor so that the maximum score for each domain is 6. The overall FSFI score can range from 2 to 36. Higher scores indicate better or higher sexual function.
Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)	Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)	as measured by Monash Women's Health Program Female Sexual Satisfaction Questionnaire (MONASH WHP FSSQ) question 11. MONASH WHP FSSQ question 11 asks participants to comment on how satisfying they found the sex to be from "Not at all" to "Very much so". The lowest score is 1 and the highest is 9. All scores for each 28-day period were averaged. Change from baseline was obtained by subtracting baseline 28-day average from the 28-day period at the end of the study (Day 57 to 84).

Trial Locations

Locations (47): Radiant Research Inc.
🇺🇸
San Antonio, Texas, United States
Medical Center for Clinical Research
🇺🇸
San Diego, California, United States
San Diego Sexual Medicine
🇺🇸
San Diego, California, United States
San Antonio Psychiatric Research Center Dba Croft Group Research Center
🇺🇸
San Antonio, Texas, United States
Thameside OB/GYN Centre
🇺🇸
Groton, Connecticut, United States
Greater Hartford Women's Health Associates
🇺🇸
Hartford, Connecticut, United States
Womens Clinic of Lincoln P.C.
🇺🇸
Lincoln, Nebraska, United States
Medical Affiliated Research Center Inc.
🇺🇸
Huntsville, Alabama, United States
Quality of Life Medical Research Center
🇺🇸
Tucson, Arizona, United States
Atlanta North Gynecology, PC
🇺🇸
Roswell, Georgia, United States
Columbus Center for Women's Health Research
🇺🇸
Columbus, Ohio, United States
Clinical Research Associates, Inc
🇺🇸
Nashville, Tennessee, United States
Center for Marital and Sexual Health of South Florida
🇺🇸
West Palm Beach, Florida, United States
Radiant Reseach
🇺🇸
Overland Park, Kansas, United States
Lillestol Research LLC
🇺🇸
Fargo, North Dakota, United States
Compass Research East LLC
🇺🇸
Oviedo, Florida, United States
Maryland Center for Sexual Health
🇺🇸
Lutherville, Maryland, United States
Women's Health Practice
🇺🇸
Champaign, Illinois, United States
Montana Health Research Institute
🇺🇸
Billings, Montana, United States
QUEST Research Institute
🇺🇸
Bingham Farms, Michigan, United States
University Hospitals Case Medical Center
🇺🇸
Mayfield Heights, Ohio, United States
Clinical Research of Philadelphia LLC
🇺🇸
Philadelphia, Pennsylvania, United States
Columbia University School of Nursing
🇺🇸
New York, New York, United States
Center for Marital and Sexual Health Inc.
🇺🇸
Beachwood, Ohio, United States
Cincinnati Urogynecology Associates (TRIHEALTH)
🇺🇸
West Chester, Ohio, United States
Manitoba Clinic
🇨🇦
Winnipeg, Manitoba, Canada
Virginia Research Center
🇺🇸
Midlothian, Virginia, United States
Monash University
🇦🇺
Melbourne, Australia
Discovery Clinical Services, Ltd
🇨🇦
Victoria, British Columbia, Canada
Women's Clincial Research Center
🇺🇸
Seattle, Washington, United States
Gain Medical Centre
🇨🇦
Coquitlam, British Columbia, Canada
The Robinson Institute University of Adelaide
🇦🇺
North Adelaide, Australia
Barbara Gross Research Unit
🇦🇺
Randwick, Australia
Victoria Clinical Research Inc
🇨🇦
Victoria, British Columbia, Canada
Alta Clinical Research Inc.
🇨🇦
Edmonton, Alberta, Canada
Downtown Women's Health Care
🇺🇸
Denver, Colorado, United States
Wake Research Associates LLC
🇺🇸
Raleigh, North Carolina, United States
Tampa Bay Medical Research Inc.
🇺🇸
Clearwater, Florida, United States
University of Florida - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Clinical Research of South Florida
🇺🇸
Coral Gables, Florida, United States
Clinical Physiology Associates
🇺🇸
Fort Myers, Florida, United States
Tidewater Physicians for Women
🇺🇸
Norfolk, Virginia, United States
Texas Diabetes and Endocrinology
🇺🇸
Round Rock, Texas, United States
Keogh Institute for Medical Research
🇦🇺
Nedlands, Australia
Manna Research
🇨🇦
Toronto, Ontario, Canada
University of Virginia Center for Psychiatric Clinical Research
🇺🇸
Charlottesville, Virginia, United States
Radiant Research
🇺🇸
Akron, Ohio, United States