Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Stopped early · Phase 4

Conditions studied: Hypoactive Sexual Desire Disorder

In brief

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.

Key facts

Study ID

NCT02714049

Run by

San Diego Sexual Medicine

People needed

23

Starts

2017-01-25

Expected to finish

2019-01-30

Last updated by the study team

2022-06-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States

Full record on ClinicalTrials.gov

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