Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride

J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.


Introduction: Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described.

Aim: Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED).

Methods: A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks.

Main outcome measures: International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs).

Results: Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders.

Conclusions: TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.

Trial registration: NCT01139762.

Keywords: 5-Alpha Reductase Inhibitors; Benign Prostatic Hyperplasia; Ejaculatory Function; Erectile Dysfunction; Finasteride; Lower Urinary Tract Symptoms; Orgasmic Function; Phosphodiesterase Type 5 Inhibitors; Tadalafil.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Carbolines / therapeutic use*
  • Coitus*
  • Comorbidity
  • Double-Blind Method
  • Drug Therapy, Combination
  • Erectile Dysfunction / drug therapy*
  • Erectile Dysfunction / etiology
  • Erectile Dysfunction / physiopathology
  • Finasteride / therapeutic use*
  • Humans
  • Lower Urinary Tract Symptoms / complications
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lower Urinary Tract Symptoms / physiopathology
  • Male
  • Middle Aged
  • Phosphodiesterase 5 Inhibitors / therapeutic use*
  • Prostatic Hyperplasia / complications
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / physiopathology
  • Tadalafil
  • Treatment Outcome


  • Carbolines
  • Phosphodiesterase 5 Inhibitors
  • Finasteride
  • Tadalafil

Associated data