• Matthew Spitzer, Shehzad Basaria, Thomas G Travison, Maithili N Davda, Amanda Paley, Beth Cohen, Norman A Mazer, Philip E Knapp, Samson Hanka, Kishore M Lakshman, Jagadish Ulloor, Anqi Zhang, Katie Orwoll, Richard Eder, Lauren Collins, Nurahmed Mohammed, Raymond C Rosen, Leonard DeRogatis, and Shalender Bhasin.
• Boston University School of Medicine, 670 Albany Street, Boston, MA 02118, USA. matthew.spitzer@bmc.org
• Ann. Intern. Med. 2012 Nov 20;157(10):681-91.

BackgroundErectile dysfunction and low testosterone levels frequently occur together.ObjectiveTo determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels.DesignRandomized, double-blind, parallel, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00512707)SettingOutpatient academic research center.ParticipantsMen 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).InterventionSildenafil 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.ResultsAt 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.LimitationWhether testosterone could improve erectile function without sildenafil was not studied.ConclusionSildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels.Primary Funding SourceNational Institute of Child Health and Human Development.

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