NCT02714049

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: San Diego Sexual Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
BEHAVIORAL	sex therapy	60 minutes each time, in person or on the telephone
DRUG	flibanserin	FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Timeline

• Start date: 2017-01-25
• Primary completion: 2019-01-18
• Completion: 2019-01-30
• First posted: 2016-03-21
• Last updated: 2022-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study