Clinical Trial: A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
Brief Summary: To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).
Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc
Current Primary Outcome: The Frequency of Adverse Events [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Original Primary Outcome: The frequency of adverse events. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Current Secondary Outcome:
Original Secondary Outcome:
- Clinically significant changes to pelvic exam. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
- Clinically significant changes to labs. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
- Clinically significant changes to overall patient status. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
- Questionnaires related to sexual health. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
- Questionnaires related to depression. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
- Questionnaires related to suicidal thoughts. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Information By: Sprout Pharmaceuticals, Inc
Dates:
Date Received: April 13, 2010
Date Started: April 2010
Date Completion:
Last Updated: April 11, 2014
Last Verified: April 2014