Flibanserin Versus Placebo in Premenopausal Women With HSDD

NCT00491829 | Completed Phase 3 Results DMC

• 1 other identifier: 511.77
• Study Type: interventional
• Target: 945
• Locations: 13 countries
• Sites: 86

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.

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.

  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?"

  baseline to 24 weeks

Study Arms (3)

flibanserin

EXPERIMENTAL

50 mg qhs

Drug: 50 mg qhs

flibanserin 100mg

EXPERIMENTAL

100 mg qhs

Drug: 100 mg

placebo

PLACEBO COMPARATOR

placebo qhs

Drug: placebo

Interventions

50 mg qhs DRUG

flibanserin 50 mg

flibanserin

100 mg DRUG

flibanserin 100mg

flibanserin 100mg

placebo DRUG

placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Women who are 18 years of age and older at the Screen Visit.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (86)

511.77.43005 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

511.77.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

511.77.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

511.77.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

511.77.43006 Boehringer Ingelheim Investigational Site

Wörgl, Austria

Location

511.77.32004 Boehringer Ingelheim Investigational Site

Braine-l'Alleud, Belgium

Location

511.77.32003 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

511.77.32005 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

511.77.32006 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

511.77.32002 Boehringer Ingelheim Investigational Site

Yvoir, Belgium

Location

511.77.42001 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

511.77.42002 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

511.77.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

511.77.42004 Boehringer Ingelheim Investigational Site

Vřesina, Czechia

Location

511.77.35801 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

511.77.35805 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

511.77.35802 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

511.77.35803 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

511.77.35804 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

511.77.3308A Boehringer Ingelheim Investigational Site

Blanquefort, France

Location

511.77.3301A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

511.77.3305A Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

511.77.3314A Boehringer Ingelheim Investigational Site

Lille, France

Location

511.77.3314B Cabinet médical

Lille, France

Location

511.77.3314C Cabinet médical

Lille, France

Location

511.77.3303A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.77.3310A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.77.3312A Boehringer Ingelheim Investigational Site

Marseille, France

Location

511.77.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

511.77.3315A Cabinet Médical

Rennes, France

Location

511.77.3306A Boehringer Ingelheim Investigational Site

Saint-Émilion, France

Location

511.77.3311A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

511.77.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

511.77.49007 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

511.77.49001 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

511.77.49006 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

511.77.49008 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

511.77.49003 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

511.77.49002 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

511.77.49005 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

511.77.49009 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

511.77.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

511.77.36005 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

511.77.36003 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

511.77.36004 Boehringer Ingelheim Investigational Site

Szentes, Hungary

Location

511.77.39004 Ospedale S. Bambino

Catania, Italy

Location

511.77.39001 IRCCS S. Fondazione Maugeri

Pavia, Italy

Location

511.77.39002 Ospedale Santa Chiara

Pisa, Italy

Location

511.77.39003 Ospedale Sant'Anna

Torino, Italy

Location

511.77.31006 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

511.77.31001 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

511.77.31004 Boehringer Ingelheim Investigational Site

Apeldoorn, Netherlands

Location

511.77.31007 Boehringer Ingelheim Investigational Site

Den Helder, Netherlands

Location

511.77.31005 Boehringer Ingelheim Investigational Site

Enschede, Netherlands

Location

511.77.31002 St Antonius ziekenhuis

Nieuwegein, Netherlands

Location

511.77.31009 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

511.77.31008 Boehringer Ingelheim Investigational Site

Tilburg, Netherlands

Location

511.77.31003 Boehringer Ingelheim Investigational Site

Zeist, Netherlands

Location

511.77.47002 Boehringer Ingelheim Investigational Site

Lillestrøm, Norway

Location

511.77.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

511.77.47003 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

511.77.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

511.77.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

511.77.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

511.77.34006 Boehringer Ingelheim Investigational Site

L´Hospitalet Del LLobregat, Spain

Location

511.77.34003 Boehringer Ingelheim Investigational Site

Manresa (Barcelona), Spain

Location

511.77.34002 Boehringer Ingelheim Investigational Site

Mataró-Barcelona, Spain

Location

511.77.34001 Boehringer Ingelheim Investigational Site

Ourense, Spain

Location

511.77.46004 Boehringer Ingelheim Investigational Site

Kungsbacka, Sweden

Location

511.77.46009 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

511.77.46007 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken

Stockholm, Sweden

Location

511.77.46002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

511.77.46006 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

511.77.46005 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

511.77.46003 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

511.77.44011 Boehringer Ingelheim Investigational Site

Belfast, United Kingdom

Location

511.77.44009 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

511.77.44004 Boehringer Ingelheim Investigational Site

Fisherwick, Lichfield, United Kingdom

Location

511.77.44008 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

511.77.44003 Boehringer Ingelheim Investigational Site

Headington, Oxford, United Kingdom

Location

511.77.44005 Boehringer Ingelheim Investigational Site

Leeds, United Kingdom

Location

511.77.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

511.77.44002 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

511.77.44007 Boehringer Ingelheim Investigational Site

South Brent, United Kingdom

Location

511.77.44010 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: Scientific Program Director
• Organization: Sprout Pharmaceuticals

clinicaltrials@sproutpharma.com

9198820850

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 2, 2014
• Results First Posted: June 2, 2014

Record last verified: 2014-05

Locations

AU (5); HU (4); NL (9); BE (5); NO (4); ES (6); SE (8); DE (9); GB (10); FR (13); FI (5); IT (4); CZ (4)