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Hypoactive Sexual Desire Disorder in Males

NCT04002661 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-26

No results posted yet for this study

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).

Conditions

  • Low Libido

Interventions

DRUG

Flibanserin

Flibanserin tablet

DRUG

Placebo

Oral Tablet

Sponsors & Collaborators

  • Sprout Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Mohit Khera

    lead OTHER

Principal Investigators

  • Mohit Khera, MD, MBA, MPH · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2025-10-31
Completion
2026-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002661 on ClinicalTrials.gov