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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00601367 |
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
Condition | Intervention | Phase |
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Sexual Dysfunctions, Psychological |
Drug: BIMT 17 BS 25 mg Drug: BIMT 17 BS 50 mg Drug: BIMT 17 BS 100 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD |
Estimated Enrollment: | 457 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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).
Exclusion Criteria:
The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 511.118 |
Study First Received: | January 15, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00601367 History of Changes |
Health Authority: | Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna; Belgium: Federal Agency for Medicines and Health Products; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Finland: National Agency for Medicines; 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 |
Sexual Dysfunctions, Psychological Mental Disorders |
Sexual Dysfunctions, Psychological Mental Disorders Sexual and Gender Disorders |