A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: flibanserin
Intervention description: all patients will receive open-label flibanserin 100mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To generate additional long-term safety and efficacy data on flibanserin in premenopausal
      women and establish long-term safety and tolerability of flibanserin in naturally
      postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior
      clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).
    

Eligibility criteria:

        Inclusion criteria:

          1. Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed
             a prior trial of flibanserin. Such completion requires compliance with trial
             medication and the trial visit schedule including any post-treatment visits required
             in that clinical trial. Early discontinuation for any reason disqualifies the patient
             from entry into this trial. Patients must enroll in this study within 7 days after
             completing the final visit of the parent trial.

          2. The premenopausal patient must use a medically acceptable method of contraception for
             at least two months before baseline and continue to use medically acceptable method of
             contraception during the trial.

          3. Postmenopausal patients must be a naturally postmenopausal woman of any age with at
             least one ovary. Natural menopause is defined as greater than 12 months of spontaneous
             amenorrhea.

          4. In the investigator's opinion, patients must be willing to adhere to trial
             requirements as well as to be able to perform them.

          5. 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 sexual functioning with study staff.

        Exclusion criteria:

          1. Patients with history of Major Depressive Disorder (MDD) within six months prior to
             the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression
             Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation
             according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist
             or psychologist, using clinical judgment, believes a patient who scored between 14 and
             19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE:
             If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to
             either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the
             Suicide Behavior section, please refer to Section 5.2.5 for immediate actions
             required.

          2. At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase,
             alkaline phosphatase, or total bilirubin greater than or equal to three times upper
             limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL),
             plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL,
             leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia
             (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL);
             or random glucose > upper limit of normal.

          3. Patients with newly developed, self-reported symptoms after the End of Treatment
             parent trial visit and at this trial Screen Visit of pelvic inflammatory disease,
             urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis,
             vulvodynia, or significant vaginal atrophy.

          4. Patients with history of any cancer within the last ten years, other than
             non-invasive, previously resected basal cell carcinoma of the skin.

          5. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any
             other pelvic or vaginal surgery.

          6. Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been
             pregnant within the month prior to the Screen Visit or who are breast-feeding or have
             breast-fed within the last six months prior to the Baseline Visit.

          7. Patients receiving medication excluded in their prior safety and efficacy trial of
             flibanserin causing sexual dysfunction or safety-relevant interactions (i.e.,
             antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).

          8. Patients with clinically relevant conditions which might interfere with their ability
             to participate in the trial.

          9. Participation in a trial of an investigational medication other than flibanserin
             within one month prior to the Screen Visit.