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Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

NCT ID: NCT00601367

Last Updated: 2014-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Sexual Dysfunctions, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

flibanserin flexible dose

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sprout Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sprout Pharmaceuticals

Role: STUDY_CHAIR

Sprout Pharmaceuticals

Locations

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511.118.43005 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

Site Status

511.118.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

511.118.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

511.118.43006 Boehringer Ingelheim Investigational Site

Wörgl, , Austria

Site Status

511.118.32004 Boehringer Ingelheim Investigational Site

Braine-l'Alleud, , Belgium

Site Status

511.118.32003 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

511.118.32005 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

511.118.32006 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

511.118.32002 Boehringer Ingelheim Investigational Site

Yvoir, , Belgium

Site Status

511.118.42001 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

Site Status

511.118.42002 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

511.118.42003 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

511.118.42004 Boehringer Ingelheim Investigational Site

Vřesina, , Czechia

Site Status

511.118.35801 Boehringer Ingelheim Investigational Site

Espoo, , Finland

Site Status

511.118.35805 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

511.118.35802 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

511.118.35803 Boehringer Ingelheim Investigational Site

Seinäjoki, , Finland

Site Status

511.118.35804 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

511.118.3308A Boehringer Ingelheim Investigational Site

Blanquefort, , France

Site Status

511.118.3301A Boehringer Ingelheim Investigational Site

Bordeaux, , France

Site Status

511.118.3305A Boehringer Ingelheim Investigational Site

La Rochelle, , France

Site Status

511.118.3314A Boehringer Ingelheim Investigational Site

Lille, , France

Site Status

511.118.3314B Cabinet médical

Lille, , France

Site Status

511.118.3303A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

511.118.3310A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

511.118.3312A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

511.118.3315A Cabinet Médical

Rennes, , France

Site Status

511.118.3306A Boehringer Ingelheim Investigational Site

Saint-Émilion, , France

Site Status

511.118.3311A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

511.118.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

511.118.49001 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

511.118.49006 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

511.118.49008 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

511.118.49003 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

511.118.49002 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

511.118.49005 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

511.118.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

511.118.36005 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

511.118.36003 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

511.118.36004 Boehringer Ingelheim Investigational Site

Szentes, , Hungary

Site Status

511.118.39004 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

511.118.39001 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

511.118.39003 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

511.118.31006 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

Site Status

511.118.31001 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

511.118.31004 Boehringer Ingelheim Investigational Site

Apeldoorn, , Netherlands

Site Status

511.118.31003 Boehringer Ingelheim Investigational Site

Bilthoven, , Netherlands

Site Status

511.118.31007 Boehringer Ingelheim Investigational Site

Den Helder, , Netherlands

Site Status

511.118.31005 Boehringer Ingelheim Investigational Site

Enschede, , Netherlands

Site Status

511.118.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, , Netherlands

Site Status

511.118.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

511.118.34003 Boehringer Ingelheim Investigational Site

Manresa (Barcelona), , Spain

Site Status

511.118.34002 Boehringer Ingelheim Investigational Site

Mataró-Barcelona, , Spain

Site Status

511.118.34001 Boehringer Ingelheim Investigational Site

Ourense, , Spain

Site Status

511.118.46004 Boehringer Ingelheim Investigational Site

Kungsbacka, , Sweden

Site Status

511.118.46009 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

511.118.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

511.118.46006 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

511.118.46005 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

511.118.46003 Boehringer Ingelheim Investigational Site

Västerås, , Sweden

Site Status

511.118.44009 Boehringer Ingelheim Investigational Site

Chorley, , United Kingdom

Site Status

511.118.44004 Boehringer Ingelheim Investigational Site

Fisherwick, Lichfield, , United Kingdom

Site Status

511.118.44008 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

511.118.44003 Boehringer Ingelheim Investigational Site

Headington, Oxford, , United Kingdom

Site Status

511.118.44001 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

511.118.44002 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

511.118.44007 Boehringer Ingelheim Investigational Site

South Brent, , United Kingdom

Site Status

511.118.44010 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia Finland France Germany Hungary Italy Netherlands Spain Sweden United Kingdom

Other Identifiers

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511.118

Identifier Type: -

Identifier Source: org_study_id

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