Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
480
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.
Frequency of Adverse Events
Time frame: 28 weeks
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511.118.43005 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
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Vienna, Austria
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Braine-l'Alleud, Belgium
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Yvoir, Belgium
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Olomouc, Czechia
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