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Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Hypoactive Sexual Desire Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Hypoactive Sexual Desire Disorder
  • Hypokinesia
  • Sexual Dysfunctions, Psychological
Clinical Trial Details
NCT number NCT02714049
Study type Interventional
Source San Diego Sexual Medicine
Contact
Status Terminated
Phase Phase 4
Start date January 25, 2017
Completion date January 30, 2019
View Details
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