NCT04743934CompletedPhase 2
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 3 Feb 2021
- Start date
- 2 Jul 2021
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Andrew McDonald
- Diseases
- Prostate cancer
- NCT number
- NCT04743934
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 2 Jul 2021 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors.
- Concurrent moderate or strong CYP3A4 inhibitors
- Concurrently taking medication classified as a monoamine oxidase inhibitor.
Other illness
- Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone.
- Current symptoms attributable to active prostate cancer
Other
- Moderate or heavy alcohol use (\>2 drinks/day)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.