A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Study Overview
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Brief Summary
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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).

Official Title
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Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

Conditions
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Sexual Dysfunctions, Psychological

Intervention / Treatment
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* Drug: flibanserin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. 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. 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. In the investigator's opinion, patients must be willing to adhere to trial requirements as well as to be able to perform them. 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: 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. 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. 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. Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery. 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. 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). Patients with clinically relevant conditions which might interfere with their ability to participate in the trial. Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flibanserin 100mg<br>flibanserin 100mg po qd | Drug: flibanserin<br>* all patients will receive open-label flibanserin 100mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Frequency of Adverse Events |  | A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD |