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Could a 'Female Viagra' drug boost libido in men on prostate cancer treatment?

NCT ID NCT04743934

Symptom relief Sponsor: Andrew McDonald 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This phase II trial tests whether flibanserin, a drug approved for low sexual desire in women, can increase sexual interest in men with prostate cancer who are receiving androgen deprivation therapy (hormone therapy). About 44 men will be randomly assigned to take flibanserin or a placebo daily at bedtime. The study measures how often participants attempt sexual intercourse and their sexual quality of life.

What this could mean

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

Active substance
flibanserin, a drug taken daily at bedtime
What this could lead to
If it works, this could offer a way to improve sexual interest and quality of life for men undergoing hormone therapy for prostate cancer.
What could go wrong
This is a small, early-phase trial, so results may not be conclusive. Flibanserin is not approved for men and may cause side effects like dizziness or low blood pressure.

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

44 people

The number who actually took part.

Started

Jul 2021

Finished

Mar 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 years and older

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: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Ability to take oral medication and be willing to adhere to the study regimen. * Male age \>18 years. * Histologically confirmed prostate cancer. * Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy. * Serum testosterone \<50 ng/dL. * Serum AST and ALT less than 2 times upper limit of normal. * Endorsed reduced sexual interest. * Attempted intercourse. * Current sexual partner. * Was sexually active with partner within 6 months prior to ADT. * No other antineoplastic therapy planned during study period. * No active symptoms attributable to systemic prostate cancer. Exclusion Criteria: * Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone. * Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors. * Current symptoms attributable to active prostate cancer * Moderate or heavy alcohol use (\>2 drinks/day) * Concurrent moderate or strong CYP3A4 inhibitors * Concurrently taking medication classified as a monoamine oxidase inhibitor.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma

As listed by the trial registrant

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

Prostate adenocarcinoma

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

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