CompletedPhase 2

Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

United States44 participantsStarted 2021-07-02

Plain-language summary

This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month

Timeframe: Baseline up to 12 weeks

Trial details

NCT IDNCT04743934

SponsorAndrew McDonald

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Results submitted2026-02-25

View on ClinicalTrials.gov More Prostate Adenocarcinoma trials