Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Phase 3

Completed

Conditions: Sexual Dysfunctions, Psychological

Interventions: Drug: flibanserin flexible dose

Registration Number: NCT00601367

Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary: Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 480

Inclusion Criteria

Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
Patients must have used a medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.

Exclusion 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, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flibanserin flexible dose	flibanserin flexible dose	Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	28 weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (68): 511.118.3310A Boehringer Ingelheim Investigational Site
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Marseille, France
511.118.3311A Boehringer Ingelheim Investigational Site
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Toulouse, France
511.118.3312A Boehringer Ingelheim Investigational Site
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Marseille, France
511.118.3314B Cabinet médical
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Lille, France
511.118.49004 Boehringer Ingelheim Investigational Site
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Berlin, Germany
511.118.3308A Boehringer Ingelheim Investigational Site
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Blanquefort, France
511.118.3305A Boehringer Ingelheim Investigational Site
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La Rochelle, France
511.118.3314A Boehringer Ingelheim Investigational Site
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Lille, France
511.118.49001 Boehringer Ingelheim Investigational Site
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Bonn, Germany
511.118.35804 Boehringer Ingelheim Investigational Site
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Tampere, Finland
511.118.3303A Boehringer Ingelheim Investigational Site
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Marseille Cedex 9, France
511.118.3315A Cabinet Médical
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Rennes, France
511.118.44009 Boehringer Ingelheim Investigational Site
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Chorley, United Kingdom
511.118.44008 Boehringer Ingelheim Investigational Site
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Glasgow, United Kingdom
511.118.46003 Boehringer Ingelheim Investigational Site
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Vasteras, Sweden
511.118.44007 Boehringer Ingelheim Investigational Site
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South Brent, United Kingdom
511.118.44002 Boehringer Ingelheim Investigational Site
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London, United Kingdom
511.118.44003 Boehringer Ingelheim Investigational Site
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Headington, Oxford, United Kingdom
511.118.44004 Boehringer Ingelheim Investigational Site
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Fisherwick, Lichfield, United Kingdom
511.118.44010 Boehringer Ingelheim Investigational Site
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Waterloo, Liverpool, United Kingdom
511.118.44001 Boehringer Ingelheim Investigational Site
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London, United Kingdom
511.118.34001 Boehringer Ingelheim Investigational Site
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Orense, Spain
511.118.32004 Boehringer Ingelheim Investigational Site
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Braine-l'Alleud, Belgium
511.118.43005 Boehringer Ingelheim Investigational Site
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Innsbruck, Austria
511.118.43006 Boehringer Ingelheim Investigational Site
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Wörgl, Austria
511.118.43004 Boehringer Ingelheim Investigational Site
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Wien, Austria
511.118.32003 Boehringer Ingelheim Investigational Site
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Edegem, Belgium
511.118.32002 Boehringer Ingelheim Investigational Site
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Yvoir, Belgium
511.118.32005 Boehringer Ingelheim Investigational Site
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Gent, Belgium
511.118.35801 Boehringer Ingelheim Investigational Site
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Espoo, Finland
511.118.42003 Boehringer Ingelheim Investigational Site
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Prague, Czech Republic
511.118.42004 Boehringer Ingelheim Investigational Site
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Vresina, Czech Republic
511.118.35802 Boehringer Ingelheim Investigational Site
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Oulu, Finland
511.118.35805 Boehringer Ingelheim Investigational Site
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Helsinki, Finland
511.118.35803 Boehringer Ingelheim Investigational Site
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Seinäjoki, Finland
511.118.3301A Boehringer Ingelheim Investigational Site
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Bordeaux Cedex, France
511.118.3306A Boehringer Ingelheim Investigational Site
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Saint Emilion, France
511.118.49006 Boehringer Ingelheim Investigational Site
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Dresden, Germany
511.118.49008 Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
511.118.49002 Boehringer Ingelheim Investigational Site
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Hannover, Germany
511.118.36001 Boehringer Ingelheim Investigational Site
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Budapest, Hungary
511.118.49005 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
511.118.36004 Boehringer Ingelheim Investigational Site
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Szentes, Hungary
511.118.36005 Boehringer Ingelheim Investigational Site
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Kecskemét, Hungary
511.118.39001 Boehringer Ingelheim Investigational Site
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Pavia, Italy
511.118.36003 Boehringer Ingelheim Investigational Site
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Szeged, Hungary
511.118.39004 Boehringer Ingelheim Investigational Site
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Catania, Italy
511.118.31003 Boehringer Ingelheim Investigational Site
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Bilthoven, Netherlands
511.118.31006 Boehringer Ingelheim Investigational Site
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Almere, Netherlands
511.118.31001 Boehringer Ingelheim Investigational Site
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Amsterdam, Netherlands
511.118.39003 Boehringer Ingelheim Investigational Site
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Torino, Italy
511.118.31004 Boehringer Ingelheim Investigational Site
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Apeldoorn, Netherlands
511.118.31007 Boehringer Ingelheim Investigational Site
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Den Helder, Netherlands
511.118.34004 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
511.118.34003 Boehringer Ingelheim Investigational Site
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Manresa (Barcelona), Spain
511.118.34002 Boehringer Ingelheim Investigational Site
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Mataró-Barcelona, Spain
511.118.46004 Boehringer Ingelheim Investigational Site
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Kungsbacka, Sweden
511.118.46009 Boehringer Ingelheim Investigational Site
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Lund, Sweden
511.118.46001 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
511.118.46006 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
511.118.46005 Boehringer Ingelheim Investigational Site
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Uppsala, Sweden
511.118.49003 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
511.118.43002 Boehringer Ingelheim Investigational Site
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Wien, Austria
511.118.31005 Boehringer Ingelheim Investigational Site
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Enschede, Netherlands
511.118.42002 Boehringer Ingelheim Investigational Site
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Prague, Czech Republic
511.118.31002 Boehringer Ingelheim Investigational Site
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Nieuwegein, Netherlands
511.118.32006 Boehringer Ingelheim Investigational Site
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Hasselt, Belgium
511.118.42001 Boehringer Ingelheim Investigational Site
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Olomouc, Czech Republic