Conditions: Sexual Dysfunctions, Psychological
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 480
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: flibanserin flexible dose
Intervention descriptions: intervention 1: 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.

Protocol document: