Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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.