Clinical Trial: Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

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

Official Title: Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

Brief Summary:

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.

Efficacy for flibanserin will be assessed vs. a parallel placebo group.


Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome:

  • Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary. [ Time Frame: baseline to 28 weeks ]

    For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.

    For satisfying sexual events:

    Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)

  • Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question. [ Time Frame: baseline to 24 weeks ]

    Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:

    0 = No desire

    1. = Low des

      Original Primary Outcome: The primary endpoints are the increases in how often women have satisfying sexual events and in how much their sexual desire increases. Both are measured by making daily entries in an electronic diary.

      Current Secondary Outcome:

      Original Secondary Outcome: Changes from baseline on diary sexual distress question and on a small number of patient-completed questions/questionnaires.

      Information By: Sprout Pharmaceuticals, Inc

      Dates:
      Date Received: August 3, 2006
      Date Started: July 2006
      Date Completion:
      Last Updated: June 6, 2016
      Last Verified: June 2016