Clinical Trial: Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
Brief Summary: The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc
Current Primary Outcome:
- Change From Baseline in the Number of Satisfying Sexual Events [ Time Frame: baseline to 24 weeks ]
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:
Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).
"Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
- Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain [ Time Frame: baseline to 24 weeks ]The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
Original Primary Outcome: Change from baseline in the number of satisfying sexual events Change from baseline in the score on the Female Sexual Function Index (FSFI) desire domain [ Time Frame: 24 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Change from baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) Change from baseline on FSDS R total score Change from baseline on FSFI total score Score on Patient Global Impression of Improvement [ Time Frame: 24 weeks ]
Information By: Sprout Pharmaceuticals, Inc
Dates:
Date Received: January 25, 2010
Date Started: January 2010
Date Completion:
Last Updated: June 16, 2014
Last Verified: June 2014
