Dutasteride in Men Receiving Testosterone Therapy: A Randomised, Double-Blind Study

Andrologia. 2015 Mar;47(2):148-52. doi: 10.1111/and.12237. Epub 2014 Feb 6.

Abstract

We investigate the impact of dutasteride on prostate specific antigen (PSA) and prostate volume in men receiving testosterone (T) therapy. Twenty-three men on stable dose T therapy were randomised to receive either dutasteride or placebo for 12 months. Serum levels of PSA, T and dihydrotestosterone (DHT) and responses to the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire (MSHQ) questionnaires were determined at baseline and at 3, 6, 9 and 12 months. Prostate volume (PV) was measured using transrectal ultrasound (TRUS) at baseline and again after 12 months. A total of 22 men (mean age 57.3) completed the study, with 11 men receiving placebo and 11 receiving dutasteride. Men receiving dutasteride had a significant decrease in PSA (-0.46 ± 0.81 ng ml(-1) ; P = 0.04) and in PV (-6.65 ± 11.0%; P = 0.03) from baseline over 12 months. DHT decreased significantly for men on dutasteride compared with men receiving placebo (P = 0.02). When compared with men who received placebo, men who received dutasteride demonstrated nonsignificant trends towards decreased PSA (-0.46 versus 0.21 ng ml(-1) ; P = 0.11), PV (-6.65% versus 3.4%; P = 0.08) and MSHQ scores (-10.2 versus 5.6; P = 0.06). Dutasteride reduces PSA and PV for men on T therapy, but perhaps less so than in men without T therapy.

Keywords: 5-alpha reductase; benign prostatic hyperplasia; dutasteride; testosterone.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 5-alpha Reductase Inhibitors / pharmacology
  • 5-alpha Reductase Inhibitors / therapeutic use*
  • Aged
  • Aged, 80 and over
  • Azasteroids / pharmacology
  • Azasteroids / therapeutic use*
  • Dihydrotestosterone / blood
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Dutasteride
  • Erectile Dysfunction / drug therapy
  • Hormone Replacement Therapy*
  • Humans
  • Longitudinal Studies
  • Lower Urinary Tract Symptoms / drug therapy
  • Male
  • Middle Aged
  • Organ Size / drug effects
  • Prostate / drug effects
  • Prostate / pathology*
  • Prostate-Specific Antigen / blood*
  • Prostatic Hyperplasia / drug therapy
  • Testosterone / blood
  • Testosterone / deficiency*
  • Testosterone / therapeutic use*
  • Treatment Outcome

Substances

  • 5-alpha Reductase Inhibitors
  • Azasteroids
  • Dihydrotestosterone
  • Testosterone
  • Prostate-Specific Antigen
  • Dutasteride