Matthew Spitzer, MD; Shehzad Basaria, MD; Thomas G. Travison, PhD; Maithili N. Davda, MPH; Amanda Paley, BA; Beth Cohen, MD; Norman A. Mazer, MD, PhD; Philip E. Knapp, MD; Samson Hanka, MD; Kishore M. Lakshman, MD; Jagadish Ulloor, PhD; Anqi Zhang, PhD; Katie Orwoll, BS; Richard Eder, BA; Lauren Collins, RNP; Nurahmed Mohammed, MD; Raymond C. Rosen, PhD; Leonard DeRogatis, PhD; Shalender Bhasin, MD
Acknowledgment: The authors thank the members of the Data and Safety Monitoring Board (Abraham Morgentaler, MD [Chair]; Leonard Marks, MD; Andre Guay, MD; and Ridwan Shabsigh, MD) and the staff of the Boston University Clinical and Translational Science Institute for their help with these studies.
Grant Support: By the National Institute of Child Health and Human Development (5R01HD047722). Additional support was provided by the Boston University Clinical and Translational Science Institute (1UL1RR025771) and Boston Claude D. Pepper Older Americans Independence Center (grant 5P30AG031679 from the National Institute on Aging).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0805.
Reproducible Research Statement: Study protocol and statistical code: Available from Dr. Bhasin (e-mail, email@example.com). Data set: Portions available through written agreements with Dr. Bhasin (e-mail, firstname.lastname@example.org) and the research sponsor (National Institute of Child Health and Human Development).
Requests for Single Reprints: Matthew Spitzer, MD, Boston University School of Medicine, 670 Albany Street, Boston, MA 02118; e-mail, email@example.com.
Current Author Addresses: Drs. Spitzer, Basaria, Travison, Cohen, Knapp, Hanka, Lakshman, Ulloor, Zhang, Mohammed, and Bhasin; Ms. Davda; Ms. Paley; Ms. Orwoll; Mr. Eder; and Ms. Collins: Section of Endocrinology, Diabetes, and Nutrition, Boston University School of Medicine and Boston Medical Center, 670 Albany Street, Boston, MA 02118.
Dr. Mazer: F. Hoffmann-La Roche Ltd, Pharma Research and Early Development, Malzgasse 30, 4070 Basel, Switzerland.
Dr. Rosen: New England Research Institutes, 9 Galen Street, Watertown, MA 02472.
Dr. DeRogatis: Maryland Center for Sexual Health, Johns Hopkins University School of Medicine, Suite 140, Building A, 1300 York Road, Lutherville, MD 21093.
Author Contributions: Conception and design: S. Basaria, N.A. Mazer, P.E. Knapp, N. Mohammed, R.C. Rosen, S. Bhasin.
Analysis and interpretation of the data: M. Spitzer, S. Basaria, T.G. Travison, M.N. Davda, N.A. Mazer, S. Hanka, J. Ulloor, A. Zhang, N. Mohammed, R.C. Rosen, S. Bhasin.
Drafting of the article: M. Spitzer, S. Basaria, T.G. Travison, A. Zhang, N. Mohammed, R.C. Rosen, S. Bhasin.
Critical revision of the article for important intellectual content: M. Spitzer, S. Basaria, T.G. Travison, N.A. Mazer, P.E. Knapp, N. Mohammed, R.C. Rosen, S. Bhasin.
Final approval of the article: M. Spitzer, S. Basaria, T.G. Travison, M.N. Davda, N. Mohammed, R.C. Rosen, L. DeRogatis, S. Bhasin.
Provision of study materials or patients: K.M. Lakshman, R. Eder, N. Mohammed.
Statistical expertise: M. Spitzer, T.G. Travison, M.N. Davda, N. Mohammed.
Obtaining of funding: N. Mohammed, S. Bhasin.
Administrative, technical, or logistic support: A. Paley, P.E. Knapp, S. Hanka, K.M. Lakshman, K. Orwoll, R. Eder, L. Collins, N. Mohammed, L. DeRogatis.
Collection and assembly of data: M. Spitzer, S. Basaria, A. Paley, B. Cohen, P.E. Knapp, S. Hanka, K.M. Lakshman, J. Ulloor, K. Orwoll, R. Eder, L. Collins, N. Mohammed, S. Bhasin.
Spitzer M, Basaria S, Travison TG, Davda MN, Paley A, Cohen B, et al. Effect of Testosterone Replacement on Response to Sildenafil Citrate in Men With Erectile Dysfunction: A Parallel, Randomized Trial. Ann Intern Med. 2012;157:681-691. doi: 10.7326/0003-4819-157-10-201211200-00004
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Published: Ann Intern Med. 2012;157(10):681-691.
This article has been corrected. The original version (PDF) is appended to this article as a supplement.
Erectile dysfunction and low testosterone levels frequently occur together.
To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels.
Randomized, double-blind, parallel, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00512707)
Outpatient academic research center.
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).
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.
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.
Whether testosterone could improve erectile function without sildenafil was not studied.
Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function in men with erectile dysfunction and low testosterone levels.
National Institute of Child Health and Human Development.
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