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NCT00601367 Clinical Trial

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Sexual Dysfunctions, Psychological Clinical Trial

Official title:
A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601367
Other study ID # 511.118
Secondary ID
Status Completed
Phase Phase 3
First received January 15, 2008
Last updated May 20, 2014
Start date January 2008
Est. completion date October 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)Spain: Ministry of Health and ConsumptionSweden: Medical Products AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 480
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Sexual Dysfunctions, Psychological

Intervention

Drug:
• flibanserin flexible dose
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.

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

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events 28 weeks Yes
See also
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Completed NCT00360529 - 24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder Phase 3
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Terminated NCT01040208 - 12 Week Safety Trial of Flibanserin in Depressed Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire and Distress Phase 3