Clinical trial NCT00491829: Flibanserin Versus Placebo in Premenopausal Women With HSDD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2007-06-26
Enrollment: 945
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: 511.77.43005 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 511.77.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 511.77.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 511.77.43004 Boehringer Ingelheim Investigational Site
city: Wörgl
country: Austria
facility: 511.77.43006 Boehringer Ingelheim Investigational Site
city: Braine-l'Alleud
country: Belgium
facility: 511.77.32004 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 511.77.32003 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 511.77.32005 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 511.77.32006 Boehringer Ingelheim Investigational Site
city: Yvoir
country: Belgium
facility: 511.77.32002 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 511.77.42001 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 511.77.42002 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 511.77.42003 Boehringer Ingelheim Investigational Site
city: Vresina
country: Czech Republic
facility: 511.77.42004 Boehringer Ingelheim Investigational Site
city: Espoo
country: Finland
facility: 511.77.35801 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 511.77.35805 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 511.77.35802 Boehringer Ingelheim Investigational Site
city: Seinäjoki
country: Finland
facility: 511.77.35803 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 511.77.35804 Boehringer Ingelheim Investigational Site
city: Blanquefort
country: France
facility: 511.77.3308A Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: 511.77.3301A Boehringer Ingelheim Investigational Site
city: La Rochelle
country: France
facility: 511.77.3305A Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 511.77.3314A Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 511.77.3314B Cabinet médical
city: Lille
country: France
facility: 511.77.3314C Cabinet médical
city: Marseille Cedex 9
country: France
facility: 511.77.3303A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 511.77.3310A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 511.77.3312A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 511.77.3302A Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 511.77.3315A Cabinet Médical
city: Saint Emilion
country: France
facility: 511.77.3306A Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 511.77.3311A Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 511.77.49004 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 511.77.49007 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 511.77.49001 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 511.77.49006 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 511.77.49008 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 511.77.49003 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 511.77.49002 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 511.77.49005 Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: 511.77.49009 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 511.77.36001 Boehringer Ingelheim Investigational Site
city: Kecskemét
country: Hungary
facility: 511.77.36005 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 511.77.36003 Boehringer Ingelheim Investigational Site
city: Szentes
country: Hungary
facility: 511.77.36004 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 511.77.39004 Ospedale S. Bambino
city: Pavia
country: Italy
facility: 511.77.39001 IRCCS S. Fondazione Maugeri
city: Pisa
country: Italy
facility: 511.77.39002 Ospedale Santa Chiara
city: Torino
country: Italy
facility: 511.77.39003 Ospedale Sant'Anna
city: Almere
country: Netherlands
facility: 511.77.31006 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 511.77.31001 Boehringer Ingelheim Investigational Site
city: Apeldoorn
country: Netherlands
facility: 511.77.31004 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 511.77.31009 Boehringer Ingelheim Investigational Site
city: Den Helder
country: Netherlands
facility: 511.77.31007 Boehringer Ingelheim Investigational Site
city: Enschede
country: Netherlands
facility: 511.77.31005 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 511.77.31002 St Antonius ziekenhuis
city: Tilburg
country: Netherlands
facility: 511.77.31008 Boehringer Ingelheim Investigational Site
city: Zeist
country: Netherlands
facility: 511.77.31003 Boehringer Ingelheim Investigational Site
city: Lillestrøm
country: Norway
facility: 511.77.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 511.77.47001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 511.77.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 511.77.47004 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 511.77.34004 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 511.77.34005 Boehringer Ingelheim Investigational Site
city: L´Hospitalet del LLobregat
country: Spain
facility: 511.77.34006 Boehringer Ingelheim Investigational Site
city: Manresa (Barcelona)
country: Spain
facility: 511.77.34003 Boehringer Ingelheim Investigational Site
city: Mataró-Barcelona
country: Spain
facility: 511.77.34002 Boehringer Ingelheim Investigational Site
city: Orense
country: Spain
facility: 511.77.34001 Boehringer Ingelheim Investigational Site
city: Kungsbacka
country: Sweden
facility: 511.77.46004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 511.77.46009 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 511.77.46007 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
city: Stockholm
country: Sweden
facility: 511.77.46002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 511.77.46006 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 511.77.46005 Boehringer Ingelheim Investigational Site
city: Västerås
country: Sweden
facility: 511.77.46003 Boehringer Ingelheim Investigational Site
city: Belfast
country: United Kingdom
facility: 511.77.44011 Boehringer Ingelheim Investigational Site
city: Chorley
country: United Kingdom
facility: 511.77.44009 Boehringer Ingelheim Investigational Site
city: Fisherwick, Lichfield
country: United Kingdom
facility: 511.77.44004 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 511.77.44008 Boehringer Ingelheim Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: 511.77.44003 Boehringer Ingelheim Investigational Site
city: Leeds
country: United Kingdom
facility: 511.77.44005 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 511.77.44001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 511.77.44002 Boehringer Ingelheim Investigational Site
city: South Brent
country: United Kingdom
facility: 511.77.44007 Boehringer Ingelheim Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: 511.77.44010 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: