Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Sponsor

San Diego Sexual Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT02714049

Collaborator

(none)

Enrollment

Location

Arms

24.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Behavioral: sex therapy Drug: flibanserin	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 25, 2017

Actual Primary Completion Date :

Jan 18, 2019

Actual Study Completion Date :

Jan 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: flibanserin Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug	Drug: flibanserin FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women Other Names: Addyi
Experimental: flibanserin and sex therapy 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 60 minutes each time, in person or on the telephone Other Names: psychotherapy Drug: flibanserin FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women Other Names: Addyi

Arm

Intervention/Treatment

Experimental: flibanserin

Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug

Drug: flibanserin

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Other Names:

Addyi

Experimental: flibanserin and sex therapy

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

60 minutes each time, in person or on the telephone

Other Names:

psychotherapy

Drug: flibanserin

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Other Names:

Addyi

Outcome Measures

Primary Outcome Measures

Desire domain of the Female Sexual Function Index (FSFI) [at weeks 8 and 20]
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.

Secondary Outcome Measures

Female Sexual Distress Scale (FSDS-DAO) [at weeks 8 and 20]
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.
Total score of the Female Sexual Function Index (FSFI) [at weeks 8 and 20]
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.

Other Outcome Measures

Patient Global Impression of Improvement (PGI-I) [at weeks 8 and 20]
The last goal is to identify those women with primary biologic based HSDD who respond to flibanserin and determine whether or not they feel concomitant sex therapy might be more beneficial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.