NCT04002661

Hypoactive Sexual Desire Disorder in Males

Hypoactive Sexual Desire Disorder in Males (10-18-40-13)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mohit Khera · Academic / Other
• Sex: Male
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Low Libido

Interventions

Type	Name	Description
DRUG	Flibanserin	Flibanserin tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2020-05-08
• Primary completion: 2025-10-31
• Completion: 2026-01-23
• First posted: 2019-06-28
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study