Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

• Status: Terminated
• Trial end date: 2019-01-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Diego Sexual Medicine

Criteria

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.