Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
- Conditions
- Sexual Dysfunctions, Psychological
- Interventions
- Drug: placebo
- Registration Number
- NCT00996372
- Lead Sponsor
- Sprout Pharmaceuticals, Inc
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 949
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description flibanserin 100mg flibanserin flibanserin 100mg po qd placebo placebo placebo one tablet po qd
- Primary Outcome Measures
Name Time Method Change From Baseline in the Number of Satisfying Sexual Events 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 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) 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).
Trial Locations
- Locations (75)
511.130.01074 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
511.130.01046 Boehringer Ingelheim Investigational Site
🇺🇸Huntsville, Alabama, United States
511.130.01042 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States
511.130.01025 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
511.130.01073 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
511.130.01030 Boehringer Ingelheim Investigational Site
🇺🇸Encinitas, California, United States
511.130.01028 Boehringer Ingelheim Investigational Site
🇺🇸Fair Oaks, California, United States
511.130.01037 Boehringer Ingelheim Investigational Site
🇺🇸Irvine, California, United States
511.130.01022 Boehringer Ingelheim Investigational Site
🇺🇸Sacramento, California, United States
511.130.01035 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
Scroll for more (65 remaining)511.130.01074 Boehringer Ingelheim Investigational Site🇺🇸Birmingham, Alabama, United States