Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desir Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00601367
First received: January 15, 2008
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Sexual Dysfunctions, Psychological
Drug: BIMT 17 BS 25 mg
Drug: BIMT 17 BS 50 mg
Drug: BIMT 17 BS 100 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

Resource links provided by NLM:


Further study details as provided by Sprout Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Frequency of Adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • FSFI desire subscale, FSDS R, PGI Improvement, CGI Improvement, Patient Benefit Evaluation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 483
Study Start Date: January 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flibanserin 50 mg Drug: BIMT 17 BS 25 mg
flibanserin 25mg
Drug: BIMT 17 BS 50 mg
flibanserin 50mg
Drug: BIMT 17 BS 100 mg
flibanserin 100mg
Experimental: flibanserin 100 mg Drug: BIMT 17 BS 25 mg
flibanserin 25mg
Drug: BIMT 17 BS 50 mg
flibanserin 50mg
Drug: BIMT 17 BS 100 mg
flibanserin 100mg
Experimental: flibanserin 25 mg Drug: BIMT 17 BS 25 mg
flibanserin 25mg
Drug: BIMT 17 BS 50 mg
flibanserin 50mg
Drug: BIMT 17 BS 100 mg
flibanserin 100mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601367

  Show 68 Study Locations
Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
Investigators
Study Chair: Sprout Pharmaceuticals Sprout Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00601367     History of Changes
Other Study ID Numbers: 511.118
Study First Received: January 15, 2008
Last Updated: June 6, 2013
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Hungary: National Institute of Pharmacy, H-1051 Budapest
Italy: Comitato Etico Centrale - Fondazione S. Maugeri IRCCS - PAVIA
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO) Parnassusplein 5 2511 VX DEN HAAG
Spain: Spanish Agency for Medicines and Health Products
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden
United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014