title: Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial.
abstract: BACKGROUND
  Erectile dysfunction and low testosterone levels frequently occur together.
  
  
  OBJECTIVE
  To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels.
  
  
  METHODS
  Randomized, double-blind, parallel, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00512707)
  
  
  METHODS
  Outpatient academic research center.
  
  
  METHODS
  Men aged 40 to 70 years with scores of 25 or less for the erectile function domain (EFD) of the International Index of Erectile Function, total testosterone levels less than 11.45 nmol/L (<330 ng/dL), or free testosterone levels less than 173.35 pmol/L (<50 pg/mL).
  
  
  METHODS
  Sildenafil dose was optimized, and 140 participants were then randomly assigned to 14 weeks of daily transdermal gel that contained 10-g testosterone for 70 participants and placebo for the remaining 70 participants. All participants were included in the primary analysis, although 10 in the testosterone group and 12 in the placebo group did not complete the study.
  
  
  RESULTS
  At baseline, the 2 groups had similar EFD scores. Administration of sildenafil alone was associated with a substantial increase in EFD score (mean, 7.7 [95% CI, 6.5 to 8.8]), but change in EFD score after randomization did not differ between the groups (difference, 2.2 [CI, -0.8 to 5.1]; P = 0.150). The findings were similar for other domains of sexual function in younger men, more obese men, and men with lower baseline testosterone levels or an inadequate response to sildenafil alone. Frequency of adverse events was similar for testosterone and placebo groups.
  
  
  CONCLUSIONS
  Whether testosterone could improve erectile function without sildenafil was not studied.
  
  
  CONCLUSIONS
  Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels.
  
  
  BACKGROUND
  National Institute of Child Health and Human Development.
authors.affiliation: Boston University School of Medicine, 670 Albany Street, Boston, MA 02118, USA. matthew.spitzer@bmc.org
authors.forename: Matthew
authors.initials: M
authors.lastname: Spitzer
authors.forename: Shehzad
authors.initials: S
authors.lastname: Basaria
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Travison
authors.forename: Maithili N
authors.initials: MN
authors.lastname: Davda
authors.forename: Amanda
authors.initials: A
authors.lastname: Paley
authors.forename: Beth
authors.initials: B
authors.lastname: Cohen
authors.forename: Norman A
authors.initials: NA
authors.lastname: Mazer
authors.forename: Philip E
authors.initials: PE
authors.lastname: Knapp
authors.forename: Samson
authors.initials: S
authors.lastname: Hanka
authors.forename: Kishore M
authors.initials: KM
authors.lastname: Lakshman
authors.forename: Jagadish
authors.initials: J
authors.lastname: Ulloor
authors.forename: Anqi
authors.initials: A
authors.lastname: Zhang
authors.forename: Katie
authors.initials: K
authors.lastname: Orwoll
authors.forename: Richard
authors.initials: R
authors.lastname: Eder
authors.forename: Lauren
authors.initials: L
authors.lastname: Collins
authors.forename: Nurahmed
authors.initials: N
authors.lastname: Mohammed
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
authors.forename: Leonard
authors.initials: L
authors.lastname: DeRogatis
authors.forename: Shalender
authors.initials: S
authors.lastname: Bhasin
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003075:Coitus; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000097:blood / Q000188:drug therapy*; D005782:Gels; D020249:Hormone Replacement Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009948:Orgasm; D010410:Penile Erection; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011687:Purines / Q000008:administration & dosage / Q000627:therapeutic use; D011788:Quality of Life; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000008:administration & dosage / Q000627:therapeutic use*; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000728:Androgens; D005782:Gels; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D013739:Testosterone; D000068677:Sildenafil Citrate