Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: flibanserin flexible dose
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 480.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility 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.