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

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 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America

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 100 mg<br>Flibanserin 100 mg administered at bedtime | Drug: Flibanserin<br>* Flibanserin 100mg administered at bedtime for 24 weeks<br>|
| Placebo Comparator: Placebo<br>This is the matched placebo which will be administered two tablets daily at bedtime. | Drug: Placebo<br>* This is the matched placebo which will be administered two tablets daily at bedtime.<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 | The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question. | baseline to 24 weeks | 
| Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain | The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains 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 (1 is lowest level of desire and 5 is the highest level of desire). 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 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36. | baseline to 24 weeks |