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Can the 'Female Viagra' boost Men's sex drive?

NCT ID NCT04002661

Symptom relief Sponsor: Mohit Khera Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tested whether flibanserin (Addyi), a drug approved for low sexual desire in women, could also help men with low libido. Eight men aged 18–69 with low desire but normal mood and erectile function took either the drug or a placebo for three months. The trial was terminated early, so firm conclusions cannot be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Flibanserin (Addyi)
What this could lead to
If it works, this could point toward a treatment for low sexual desire in men.
What could go wrong
This was a very small, early-stage trial that was terminated early, so results are limited. Flibanserin is already approved for women, but its safety and effectiveness in men are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

May 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men age 18 through 69 years old * Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C) * Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D) * Men with good erectile function as defined by IIEF greater than 22 * Men with normal testosterone and liver function values (may be on testosterone therapy) * Men who are satisfied in their relationship or with their partners * Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit. * Willing to give informed consent Exclusion Criteria: * Hypogonadal patients (less than 350 ng/dL) * IIEF-EF less than 22 * CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor * Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT * Men with normal to high libido * Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater. * Men who are stressed or fatigued as determined by the PI * Men with partners who have low libido as determined by the PI * Men with pre-existing conditions that might predispose to hypertension * Men who are not willing to meet the requirements for drinking alcohol during their participation in the study * Men who are taking digoxin

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Conditions

The condition(s) this trial relates to.

erectile dysfunction hypoactive sexual desire disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low libido

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.