Clinical Trial: 24-week Placebo-controlled Trial of Flibanserin Once Daily 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 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire

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: This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome:

  • Satisfying Sexual Event Monthly Change From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]
    Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.
  • Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]

    Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout 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", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):

    0 = No desire

    1. = Low desire
    2. = Moderate desire
    3. = Strong desire

    Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily 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:

    • Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]

      Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.

      The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is '52' (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire).

    • Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]
      Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.
    • Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]
      Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).
    • Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit [ Time Frame: Baseline, Week 24 ]
      The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from '0' to '5.' The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.
    • Patient Benefit Evaluation [ Time Frame: Week 24 ]
      The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question ("Overall, do you believe that you have experienced a meaningful benefit from the study medication?") was asked upon treatment discontinuation.


    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