Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Study Overview
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Brief Summary
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The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Official Title
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24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States

Conditions
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Sexual Dysfunctions, Psychological

Intervention / Treatment
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* Drug: flibanserin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Naturally postmenopausal women of any age with at least one ovary Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration Stable, monogamous heterosexual relationship for at least one year Willing to discuss sexual issues Willing to engage in sexual activity at least once a month Normal Pap smear Normal mammogram Normal uterine lining Able to comply with daily use of handheld data entry device Exclusion criteria: Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition Partner with inadequately treated organic or psychosexual dysfunction Sexual function impaired by psychiatric disorder Sexual function impaired by gynecological disorder Major Depression Suicidal behavior or ideation Major life stress that could impair sexual function Substance abuse

Ages Eligible for Study
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Minimum Age: 35 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flibanserin 100mg<br>flibanserin 100mg po qd | Drug: flibanserin<br>* patients will be randomized to flibanserin or placebo in a double-blind manner<br>|
| Placebo Comparator: placebo<br>placebo one tablet po qd | Drug: placebo<br>* patients will be randomized to flibanserin or placebo in a double-blind manner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Satisfying Sexual Events | A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past. | baseline through 24 weeks | 
| Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire). | baseline through 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) | The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always). | change from baseline to 24 weeks |