Clinical Trial: Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

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

Official Title: A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual

Brief Summary: The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome:

  • The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [ Time Frame: 24 weeks ]
    The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 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 on the desire domain, the higher the level of reported sexual desire.
  • Change From Baseline in the SSE Count From Baseline to 24 Weeks [ Time Frame: 24 weeks ]

    The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The 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.

    An eDiary was used by the 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

    Original Primary Outcome: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [ Time Frame: 24 weeks ]

    Current Secondary Outcome:

    Original Secondary Outcome: Change from baseline in the number of SSE as measured by the eDiary; Change from baseline in the SSE count; Change from baseline to week 24 on the FSFI total score; Change from baseline to Week 24 on Question 13 of the FSDS R [ Time Frame: 24 weeks ]

    Information By: Sprout Pharmaceuticals, Inc

    Dates:
    Date Received: October 15, 2009
    Date Started: October 2009
    Date Completion:
    Last Updated: April 16, 2014
    Last Verified: April 2014