Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy (NCT02714049) | Clinical Trial Compass
TerminatedPhase 4
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Stopped: Investor Initiated Grant support stopped when drug was sold.
United States23 participantsStarted 2017-01-25
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
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;
What they're measuring
1
Desire domain of the Female Sexual Function Index (FSFI)