Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
- Conditions
- Female Orgasmic Disorder
- Interventions
- Drug: PlaceboDrug: High dose TBS-2Drug: Medium dose TBS-2Drug: 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
Not provided
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
🇺🇸Akron, Ohio, United States
Medical Affiliated Research Center Inc.
🇺🇸Huntsville, Alabama, United States
Radiant Research Inc.
🇺🇸San Antonio, Texas, United States
Quality of Life Medical Research Center
🇺🇸Tucson, Arizona, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
San Diego Sexual Medicine
🇺🇸San Diego, California, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Thameside OB/GYN Centre
🇺🇸Groton, Connecticut, United States
Greater Hartford Women's Health Associates
🇺🇸Hartford, Connecticut, United States
Tampa Bay Medical Research Inc.
🇺🇸Clearwater, Florida, United States
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