Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Study Overview
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Brief Summary
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Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.

Detailed Description
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This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.

Official Title
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Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Behavioral: sex therapy
* Drug: flibanserin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted; Subject is female; Subject is ≥18 years old; Subject has biologic-based HSDD as her primary sexual complaint; Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening; Subject scores >18 on FSDS-DAO; Subject answers yes to questions 1-4 on the DSDS screener; Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization); Subject agrees to comply with the study procedures and visits. Exclusion Criteria: Subject has sexual pain; Subject does not have generalized, acquired HSDD; Subject has used flibanserin in the last 6 months; Subject has history of alcohol or drug abuse; Subject uses tobacco in any form; Subject is currently using androgen therapy and unwilling to washout; Subject is pregnant, nursing, or planning to become pregnant over the next 6 months; Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor; Subject is taking a CYP3A4 inducer; P-glycoprotein substrate; Subject has a history of liver impairment; Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study; Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flibanserin<br>Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug | Drug: flibanserin<br>* FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women<br>* Other names: Addyi;|
| Experimental: flibanserin and sex therapy<br>Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits | Behavioral: sex therapy<br>* 60 minutes each time, in person or on the telephone<br>* Other names: psychotherapy;Drug: flibanserin<br>* FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women<br>* Other names: Addyi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire domain of the Female Sexual Function Index (FSFI) | The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication. | at weeks 8 and 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Distress Scale (FSDS-DAO) | One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the Female Sexual Distress Scale (FSDS-DAO) in women who respond to the study medication. | at weeks 8 and 20 | 
| Total score of the Female Sexual Function Index (FSFI) | One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the total FSFI score respectively in women who respond to the study medication. | at weeks 8 and 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoactive sexual desire disorder, Addyi, flibanserin, low sexual desire, HSDD