Flibanserin Versus Placebo in Premenopausal Women With HSDD

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491829
• Other study ID #: 511.77
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2007
• Last updated: May 6, 2014
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2014
• Source: Sprout Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencySpain: Ministry of Health and ConsumptionSweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 945
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

2. 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

3. A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.

4. Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit

5. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.

6. 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).

7. 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.

8. 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:

1. 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.

2. 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.

3. 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

4. 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.

5. Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.

6. 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.

7. 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• 50 mg qhs
flibanserin 50 mg
• 100 mg
flibanserin 100mg
• placebo
placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No