Clinical Trial

Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia

Study acronym: DTT-BPH
Completed Phase 4
View on ClinicalTrials.gov →
Summary
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Trial Details
NCT Number NCT07715448
Lead Sponsor Beni-Suef University
Conditions Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Erectile Dysfunction
Enrollment 240 participants
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-20