Flibanserin Versus Placebo in Premenopausal Women With HSDD

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: 50 mg qhs
Drug: 100 mg
Drug: placebo

Registration Number: NCT00491829

Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 945

Inclusion Criteria

Women who are 18 years of age and older at the Screen Visit.
Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement
A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.
Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an eDiary on a daily basis (e.g., have access to a working land line or wireless telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately, having missing entries for five or less days during the 28-day Screen period.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present (i.e., available for sexual activity at some time during a 24 hour day) at least 50% of each month during the 4-week Screen period and 24-week efficacy period of the trial.

Exclusion Criteria

Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study.
Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy.
Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year
Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.
Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage [i.e., have had hysterectomy (without bilateral oophorectomy), bilateral oophorectomy, endometrial ablation (any type), and chemical induced (e.g., chemotherapy)] according to the STRAW criteria.
Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory© II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flibanserin	50 mg qhs	50 mg qhs
flibanserin 100mg	100 mg	100 mg qhs
placebo	placebo	placebo qhs

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.	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?"

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (86): 511.77.3301A Boehringer Ingelheim Investigational Site
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Bordeaux, France
511.77.3305A Boehringer Ingelheim Investigational Site
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La Rochelle, France
511.77.32005 Boehringer Ingelheim Investigational Site
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Gent, Belgium
511.77.34001 Boehringer Ingelheim Investigational Site
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Orense, Spain
511.77.32002 Boehringer Ingelheim Investigational Site
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Yvoir, Belgium
511.77.32004 Boehringer Ingelheim Investigational Site
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Braine-l'Alleud, Belgium
511.77.31001 Boehringer Ingelheim Investigational Site
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Amsterdam, Netherlands
511.77.31005 Boehringer Ingelheim Investigational Site
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Enschede, Netherlands
511.77.31008 Boehringer Ingelheim Investigational Site
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Tilburg, Netherlands
511.77.46002 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
511.77.39004 Ospedale S. Bambino
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Catania, Italy
511.77.39003 Ospedale Sant'Anna
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Torino, Italy
511.77.3314C Cabinet médical
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Lille, France
511.77.43002 Boehringer Ingelheim Investigational Site
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Wien, Austria
511.77.34004 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
511.77.34005 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
511.77.31004 Boehringer Ingelheim Investigational Site
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Apeldoorn, Netherlands
511.77.31009 Boehringer Ingelheim Investigational Site
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Den Haag, Netherlands
511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
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Stockholm, Sweden
511.77.46006 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
511.77.39001 IRCCS S. Fondazione Maugeri
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Pavia, Italy
511.77.44004 Boehringer Ingelheim Investigational Site
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Fisherwick, Lichfield, United Kingdom
511.77.34003 Boehringer Ingelheim Investigational Site
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Manresa (Barcelona), Spain
511.77.31002 St Antonius ziekenhuis
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Nieuwegein, Netherlands
511.77.31003 Boehringer Ingelheim Investigational Site
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Zeist, Netherlands
511.77.46004 Boehringer Ingelheim Investigational Site
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Kungsbacka, Sweden
511.77.39002 Ospedale Santa Chiara
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Pisa, Italy
511.77.3315A Cabinet Médical
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Rennes, France
511.77.31007 Boehringer Ingelheim Investigational Site
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Den Helder, Netherlands
511.77.46007 Boehringer Ingelheim Investigational Site
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Malmö, Sweden
511.77.36003 Boehringer Ingelheim Investigational Site
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Szeged, Hungary
511.77.44011 Boehringer Ingelheim Investigational Site
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Belfast, United Kingdom
511.77.44005 Boehringer Ingelheim Investigational Site
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Leeds, United Kingdom
511.77.34006 Boehringer Ingelheim Investigational Site
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L´Hospitalet del LLobregat, Spain
511.77.44008 Boehringer Ingelheim Investigational Site
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Glasgow, United Kingdom
511.77.44002 Boehringer Ingelheim Investigational Site
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London, United Kingdom
511.77.42004 Boehringer Ingelheim Investigational Site
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Vresina, Czech Republic
511.77.35805 Boehringer Ingelheim Investigational Site
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Helsinki, Finland
511.77.47002 Boehringer Ingelheim Investigational Site
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Lillestrøm, Norway
511.77.47001 Boehringer Ingelheim Investigational Site
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Oslo, Norway
511.77.44010 Boehringer Ingelheim Investigational Site
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Waterloo, Liverpool, United Kingdom
511.77.34002 Boehringer Ingelheim Investigational Site
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Mataró-Barcelona, Spain
511.77.43005 Boehringer Ingelheim Investigational Site
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Innsbruck, Austria
511.77.43006 Boehringer Ingelheim Investigational Site
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Wörgl, Austria
511.77.43001 Boehringer Ingelheim Investigational Site
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Wien, Austria
511.77.43004 Boehringer Ingelheim Investigational Site
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Wien, Austria
511.77.32003 Boehringer Ingelheim Investigational Site
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Edegem, Belgium
511.77.32006 Boehringer Ingelheim Investigational Site
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Hasselt, Belgium
511.77.35804 Boehringer Ingelheim Investigational Site
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Tampere, Finland
511.77.35803 Boehringer Ingelheim Investigational Site
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Seinäjoki, Finland
511.77.3314A Boehringer Ingelheim Investigational Site
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Lille, France
511.77.3303A Boehringer Ingelheim Investigational Site
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Marseille Cedex 9, France
511.77.3310A Boehringer Ingelheim Investigational Site
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Marseille, France
511.77.49004 Boehringer Ingelheim Investigational Site
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Berlin, Germany
511.77.3306A Boehringer Ingelheim Investigational Site
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Saint Emilion, France
511.77.3311A Boehringer Ingelheim Investigational Site
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Toulouse, France
511.77.49007 Boehringer Ingelheim Investigational Site
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Bochum, Germany
511.77.49008 Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
511.77.49006 Boehringer Ingelheim Investigational Site
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Dresden, Germany
511.77.49009 Boehringer Ingelheim Investigational Site
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Magdeburg, Germany
511.77.36001 Boehringer Ingelheim Investigational Site
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Budapest, Hungary
511.77.3314B Cabinet médical
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Lille, France
511.77.49001 Boehringer Ingelheim Investigational Site
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Bonn, Germany
511.77.3308A Boehringer Ingelheim Investigational Site
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Blanquefort, France
511.77.31006 Boehringer Ingelheim Investigational Site
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Almere, Netherlands
511.77.3302A Boehringer Ingelheim Investigational Site
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Paris, France
511.77.46009 Boehringer Ingelheim Investigational Site
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Lund, Sweden
511.77.3312A Boehringer Ingelheim Investigational Site
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Marseille, France
511.77.49003 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
511.77.49005 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
511.77.49002 Boehringer Ingelheim Investigational Site
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Hannover, Germany
511.77.46005 Boehringer Ingelheim Investigational Site
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Uppsala, Sweden
511.77.46003 Boehringer Ingelheim Investigational Site
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Västerås, Sweden
511.77.44003 Boehringer Ingelheim Investigational Site
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Headington, Oxford, United Kingdom
511.77.44009 Boehringer Ingelheim Investigational Site
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Chorley, United Kingdom
511.77.44001 Boehringer Ingelheim Investigational Site
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London, United Kingdom
511.77.44007 Boehringer Ingelheim Investigational Site
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South Brent, United Kingdom
511.77.35801 Boehringer Ingelheim Investigational Site
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Espoo, Finland
511.77.35802 Boehringer Ingelheim Investigational Site
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Oulu, Finland
511.77.42001 Boehringer Ingelheim Investigational Site
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Olomouc, Czech Republic
511.77.42002 Boehringer Ingelheim Investigational Site
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Prague, Czech Republic
511.77.36004 Boehringer Ingelheim Investigational Site
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Szentes, Hungary
511.77.36005 Boehringer Ingelheim Investigational Site
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Kecskemét, Hungary
511.77.47004 Boehringer Ingelheim Investigational Site
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Oslo, Norway
511.77.42003 Boehringer Ingelheim Investigational Site
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Prague, Czech Republic
511.77.47003 Boehringer Ingelheim Investigational Site
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Oslo, Norway