Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
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|ClinicalTrials.gov Identifier: NCT01607658|
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : August 13, 2018
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Female Orgasmic Disorder||Drug: Placebo Drug: Low dose TBS-2 Drug: Medium dose TBS-2 Drug: High dose TBS-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||253 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Placebo Comparator: Placebo
Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
Experimental: Experimental 1
Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn
Drug: Low dose TBS-2
Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
Experimental: Experimental 2
Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn
Drug: Medium dose TBS-2
Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
Experimental: Experimental 3
High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn
Drug: High dose TBS-2
High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
- Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period [ Time Frame: 84 days ]
- Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0) [ Time Frame: 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).
- Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84 [ Time Frame: 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 , rarely , occasionally , frequently , or always ). Higher scores indicate more distress.
- Change in Global Sexual Functioning From Day 0 to Day 84 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607658
|Study Director:||Natalia Tkachenko, MD||Trimel Pharmaceuticals Corporation|