Clinical Trial: Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States

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 through 24 weeks ]
    A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
  • Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain [ Time Frame: baseline through 24 weeks ]
    The FSFI© is a brief, self-administered questionnaire to assess key dimensions 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 (with 1 being the lowest report of desire and 5 being the highest). 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 to 6.0 (the higher the score, the higher the reported level of desire).


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: Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) [ Time Frame: change from baseline to 24 weeks ]

The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).


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: October 15, 2009
Date Started: October 2009
Date Completion:
Last Updated: May 14, 2014
Last Verified: May 2014