Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04743934

Run by

Andrew McDonald

People needed

44

Starts

2021-07-02

Expected to finish

2026-03-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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