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Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

NCT04743934 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-05-04

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma

Interventions

DRUG

Flibanserin 100 MG

Flibanserin 100mg tablets taken by mouth daily at bedtime

DRUG

Placebo

Visually identical placebo tablets taken by mouth daily at bedine

DRUG

Androgen deprivation therapy

Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Andrew McDonald

    lead OTHER

Principal Investigators

  • Andrew McDonald, MD · University of Alabama at Birmingham (UAB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2025-03-01
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04743934 on ClinicalTrials.gov