Flibanserin Versus Placebo in Premenopausal Women With HSDD
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
To evaluate safety and tolerability of flibanserin in such patients.
|Sexual Dysfunctions, Psychological||Drug: 50 mg qhs Drug: 100 mg Drug: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder|
- Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. [ Time Frame: baseline to 24 weeks ]To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"
|Study Start Date:||June 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
50 mg qhs
Drug: 50 mg qhs
flibanserin 50 mg
Experimental: flibanserin 100mg
100 mg qhs
Drug: 100 mg
Placebo Comparator: placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491829
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|