Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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

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.

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.

Inclusion Criteria:

1. Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
2. Subject is female;
3. Subject is ≥18 years old;
4. Subject has biologic-based HSDD as her primary sexual complaint;
5. Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
6. Subject scores >18 on FSDS-DAO;
7. Subject answers yes to questions 1-4 on the DSDS screener;
8. Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
9. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Subject has sexual pain;
2. Subject does not have generalized, acquired HSDD;
3. Subject has used flibanserin in the last 6 months;
4. Subject has history of alcohol or drug abuse;
5. Subject uses tobacco in any form;
6. Subject is currently using androgen therapy and unwilling to washout;
7. Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
8. Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
9. Subject is taking a CYP3A4 inducer;
10. P-glycoprotein substrate;
11. Subject has a history of liver impairment;
12. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
13. 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.