Clinical trial NCT00601367: Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Official title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: 511.118.43005 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 511.118.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 511.118.43004 Boehringer Ingelheim Investigational Site
city: Wörgl
country: Austria
facility: 511.118.43006 Boehringer Ingelheim Investigational Site
city: Braine-l'Alleud
country: Belgium
facility: 511.118.32004 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 511.118.32003 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 511.118.32005 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 511.118.32006 Boehringer Ingelheim Investigational Site
city: Yvoir
country: Belgium
facility: 511.118.32002 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 511.118.42001 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 511.118.42002 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 511.118.42003 Boehringer Ingelheim Investigational Site
city: Vresina
country: Czech Republic
facility: 511.118.42004 Boehringer Ingelheim Investigational Site
city: Espoo
country: Finland
facility: 511.118.35801 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 511.118.35805 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 511.118.35802 Boehringer Ingelheim Investigational Site
city: Seinäjoki
country: Finland
facility: 511.118.35803 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 511.118.35804 Boehringer Ingelheim Investigational Site
city: Blanquefort
country: France
facility: 511.118.3308A Boehringer Ingelheim Investigational Site
city: Bordeaux Cedex
country: France
facility: 511.118.3301A Boehringer Ingelheim Investigational Site
city: La Rochelle
country: France
facility: 511.118.3305A Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 511.118.3314A Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 511.118.3314B Cabinet médical
city: Marseille Cedex 9
country: France
facility: 511.118.3303A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 511.118.3310A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 511.118.3312A Boehringer Ingelheim Investigational Site
city: Rennes
country: France
facility: 511.118.3315A Cabinet Médical
city: Saint Emilion
country: France
facility: 511.118.3306A Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 511.118.3311A Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 511.118.49004 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 511.118.49001 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 511.118.49006 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 511.118.49008 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 511.118.49003 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 511.118.49002 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 511.118.49005 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 511.118.36001 Boehringer Ingelheim Investigational Site
city: Kecskemét
country: Hungary
facility: 511.118.36005 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 511.118.36003 Boehringer Ingelheim Investigational Site
city: Szentes
country: Hungary
facility: 511.118.36004 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 511.118.39004 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 511.118.39001 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 511.118.39003 Boehringer Ingelheim Investigational Site
city: Almere
country: Netherlands
facility: 511.118.31006 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 511.118.31001 Boehringer Ingelheim Investigational Site
city: Apeldoorn
country: Netherlands
facility: 511.118.31004 Boehringer Ingelheim Investigational Site
city: Bilthoven
country: Netherlands
facility: 511.118.31003 Boehringer Ingelheim Investigational Site
city: Den Helder
country: Netherlands
facility: 511.118.31007 Boehringer Ingelheim Investigational Site
city: Enschede
country: Netherlands
facility: 511.118.31005 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 511.118.31002 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 511.118.34004 Boehringer Ingelheim Investigational Site
city: Manresa (Barcelona)
country: Spain
facility: 511.118.34003 Boehringer Ingelheim Investigational Site
city: Mataró-Barcelona
country: Spain
facility: 511.118.34002 Boehringer Ingelheim Investigational Site
city: Orense
country: Spain
facility: 511.118.34001 Boehringer Ingelheim Investigational Site
city: Kungsbacka
country: Sweden
facility: 511.118.46004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 511.118.46009 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 511.118.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 511.118.46006 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 511.118.46005 Boehringer Ingelheim Investigational Site
city: Vasteras
country: Sweden
facility: 511.118.46003 Boehringer Ingelheim Investigational Site
city: Chorley
country: United Kingdom
facility: 511.118.44009 Boehringer Ingelheim Investigational Site
city: Fisherwick, Lichfield
country: United Kingdom
facility: 511.118.44004 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 511.118.44008 Boehringer Ingelheim Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: 511.118.44003 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 511.118.44001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 511.118.44002 Boehringer Ingelheim Investigational Site
city: South Brent
country: United Kingdom
facility: 511.118.44007 Boehringer Ingelheim Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: 511.118.44010 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Sprout Pharmaceuticals
name: Sprout Pharmaceuticals
role: STUDY_CHAIR
References: