24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: flibanserin
Intervention description: flibanserin placebo versus 50 mg qhs versus 100 mg qhs
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 880.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is designed to assess the safety and efficacy of flibanserin in the treatment of
      premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard
      diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women who are 18 years of age and older.

          2. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual
             desire), generalized acquired type, according to DSM IV-TR criteria.

          3. Patient must meet minimum cut-off scores on questionnaires relating to sexual
             functioning and sexual distress.

          4. Patients must be willing to try to have sexual activity (e.g., any act involving
             direct genital stimulation) at least once monthly.

          5. Patients must be willing and able to use an electronic diary (eDiary) on a daily basis
             (e.g., have access to a working land line telephone for daily data transmissions).

          6. At the Baseline Visit, patients must have complied with eDiary use adequately.

          7. Patients must be in a stable, monogamous, heterosexual relationship that is secure and
             communicative, for at least 1 year prior to the Screen Visit. The partner is expected
             to be physically present at least 50% of each month.

          8. Patients must have used a medically acceptable method of contraception for at least 3
             months before the Baseline Visit (Visit 2) and continue to use that medically
             acceptable method of contraception during the trial.

          9. In the investigators opinion, patients must be reliable, honest, compliant, and agree
             to co-operate with all trial evaluations as well as to be able to perform them.

         10. Patients must be able and willing to give meaningful, written informed consent prior
             to participation in the trial, in accordance with regulatory requirements. Patients
             must have sufficient understanding to communicate effectively with the investigator,
             and be willing to discuss their sexual functioning with the investigative staff.

         11. 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 Screen Visit.

        Exclusion Criteria:

          1. Patients who have taken any medication noted in the protocols List of Prohibited
             Medications within 30 days before screening.

          2. Patients whose sexual function was affected (enhanced or worsened) in the
             investigators opinion by any medication within 30 days before the Screen Visit and
             anytime prior to the Baseline Visit.

          3. Patients with a history of drug dependence or abuse within the past one year.

          4. Patients with a history of multiple severe reactions (i.e., allergic or
             oversensitivity to usual doses) to drugs that affect the brain.

          5. Patients with a history of participation in a trial of another investigational
             medication within one month prior to the Screen Visit, or participation in any
             previous clinical trial of flibanserin.

          6. Patients who meet accepted diagnostic criteria for sexual disorders that would
             interfere with improvement in HSDD (sexual aversion, substance-induced sexual
             problems, urge to live as a man, etc.

          7. Patients who indicate that their sexual partner has inadequately treated sexual
             problems that could interfere with the patients response to treatment.

          8. Patients who have entered the menopausal transition or menopause or have had a
             hysterectomy.

          9. Patients with findings at the Screen Visit of infection, inflammation, undue
             tenderness, or shrinkage (atrophy) of the female organs.

         10. Patients who are breast feeding or have breastfed within the last 6 months prior to
             the Baseline Visit.

         11. Patients who are pregnant or have been pregnant within the last 6 months prior to the
             Baseline Visit.

         12. Patients with a history of Major Depressive Disorder within 6 months prior the Screen
             Visit, a score indicating depression on a depression scale, a history of suicide
             attempt, or current suicidal ideation evident at the Screen or Baseline Visit.

         13. Patients with a history of any other psychiatric disorders that could impact sexual
             function, risks patients safety, or may impact compliance.

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