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Clinical Trial Summary

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).


Clinical Trial Description

This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night. There will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04002661
Study type Interventional
Source Baylor College of Medicine
Contact Mohit Khera, MD, MBA, MPH
Phone 713-798-6593
Email mkhera@bcm.edu
Status Recruiting
Phase Phase 2
Start date May 8, 2020
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT02070029 - Acupuncture for Sexual Dysfunction N/A