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

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: Placebo
Drug: Flibanserin

Registration Number: NCT00996164

Lead Sponsor: Sprout Pharmaceuticals, Inc

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1090

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo 1 tab po qd
flibanserin 100 mg	Flibanserin	flibanserin 100mg po qd

Primary Outcome Measures

Name	Time	Method
The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.	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	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 with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (75): 511.147.01074 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
511.147.01046 Boehringer Ingelheim Investigational Site
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Huntsville, Alabama, United States
511.147.01042 Boehringer Ingelheim Investigational Site
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Mobile, Alabama, United States
511.147.01025 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
511.147.01073 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
511.147.01030 Boehringer Ingelheim Investigational Site
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Encinitas, California, United States
511.147.01028 Boehringer Ingelheim Investigational Site
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Fair Oaks, California, United States
511.147.01037 Boehringer Ingelheim Investigational Site
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Irvine, California, United States
511.147.01022 Boehringer Ingelheim Investigational Site
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Sacramento, California, United States
511.147.01035 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
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511.147.01074 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States