Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

NCT00601367 | Completed Phase 3 Results DMC

• 1 other identifier: 511.118
• Study Type: interventional
• Target: 480
• Locations: 12 countries
• Sites: 68

Brief Summary

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

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

  28 weeks

Study Arms (1)

flibanserin flexible dose

EXPERIMENTAL

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.

Drug: flibanserin flexible dose

Interventions

flibanserin flexible dose 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.

flibanserin flexible dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (68)

511.118.43005 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

511.118.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

511.118.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

511.118.43006 Boehringer Ingelheim Investigational Site

Wörgl, Austria

Location

511.118.32004 Boehringer Ingelheim Investigational Site

Braine-l'Alleud, Belgium

Location

511.118.32003 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

511.118.32005 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

511.118.32006 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

511.118.32002 Boehringer Ingelheim Investigational Site

Yvoir, Belgium

Location

511.118.42001 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

511.118.42002 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

511.118.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

511.118.42004 Boehringer Ingelheim Investigational Site

Vřesina, Czechia

Location

511.118.35801 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

511.118.35805 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

511.118.35802 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

511.118.35803 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

511.118.35804 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

511.118.3308A Boehringer Ingelheim Investigational Site

Blanquefort, France

Location

511.118.3301A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

511.118.3305A Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

511.118.3314A Boehringer Ingelheim Investigational Site

Lille, France

Location

511.118.3314B Cabinet médical

Lille, France

Location

511.118.3303A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.118.3310A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.118.3312A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.118.3315A Cabinet Médical

Rennes, France

Location

511.118.3306A Boehringer Ingelheim Investigational Site

Saint-Émilion, France

Location

511.118.3311A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

511.118.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

511.118.49001 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

511.118.49006 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

511.118.49008 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

511.118.49003 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

511.118.49002 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

511.118.49005 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

511.118.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

511.118.36005 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

511.118.36003 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

511.118.36004 Boehringer Ingelheim Investigational Site

Szentes, Hungary

Location

511.118.39004 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

511.118.39001 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

511.118.39003 Boehringer Ingelheim Investigational Site

Torino, Italy

Location

511.118.31006 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

511.118.31001 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

511.118.31004 Boehringer Ingelheim Investigational Site

Apeldoorn, Netherlands

Location

511.118.31003 Boehringer Ingelheim Investigational Site

Bilthoven, Netherlands

Location

511.118.31007 Boehringer Ingelheim Investigational Site

Den Helder, Netherlands

Location

511.118.31005 Boehringer Ingelheim Investigational Site

Enschede, Netherlands

Location

511.118.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, Netherlands

Location

511.118.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

511.118.34003 Boehringer Ingelheim Investigational Site

Manresa (Barcelona), Spain

Location

511.118.34002 Boehringer Ingelheim Investigational Site

Mataró-Barcelona, Spain

Location

511.118.34001 Boehringer Ingelheim Investigational Site

Ourense, Spain

Location

511.118.46004 Boehringer Ingelheim Investigational Site

Kungsbacka, Sweden

Location

511.118.46009 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

511.118.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

511.118.46006 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

511.118.46005 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

511.118.46003 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

511.118.44009 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

511.118.44004 Boehringer Ingelheim Investigational Site

Fisherwick, Lichfield, United Kingdom

Location

511.118.44008 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

511.118.44003 Boehringer Ingelheim Investigational Site

Headington, Oxford, United Kingdom

Location

511.118.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

511.118.44002 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

511.118.44007 Boehringer Ingelheim Investigational Site

South Brent, United Kingdom

Location

511.118.44010 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Krista Barbour, Ph.D.
• Organization: Sprout Pharmaceuticals

kbarbour@sproutpharma.com

9198820850

Study Officials

• Sprout Pharmaceuticals

  Sprout Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 20, 2014
• Results First Posted: June 20, 2014

Record last verified: 2014-05

Locations

ES (4); IT (3); FR (11); FI (5); SE (6); HU (4); DE (7); CZ (4); NL (7); GB (8); AU (4); BE (5)