This phase II trial tests whether flibanserin works to increase interest in sex in men receiving androgen suppression for prostate cancer. Flibanserin is in a class of medications called a serotonin receptor 1A agonist/serotonin receptor 2A antagonist. It works by changing the activity of serotonin and other natural substances in the brain. Giving flibanserin may increase interest in sex in men receiving androgen suppression for prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04743934.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Estimate the efficacy of flibanserin to improve frequency of sexual activity in men receiving androgen deprivation therapy (ADT) for prostate cancer.
SECONDARY OBJECTIVES:
I. Compare quality of life (QoL) between men receiving flibanserin or placebo.
II. Confirm safety of flibanserin 100 mg daily in men receiving ADT for prostate cancer.
OUTLINE: Patients are randomized to 1 of 2 arms
ARM I: Patients receive flibanserin orally (PO) once daily (QD) for 12 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity.
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorAndrew Michael McDonald
