Flibanserin Versus Placebo in Premenopausal Women With HSDD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00491829|
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sexual Dysfunctions, Psychological||Drug: 50 mg qhs Drug: 100 mg Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||945 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
50 mg qhs
Drug: 50 mg qhs
flibanserin 50 mg
Experimental: flibanserin 100mg
100 mg qhs
Drug: 100 mg
Placebo Comparator: placebo
- 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?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491829
Show 86 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|