MedicalResearch.com Interview with:
Glenn Cunningham, MD
Departments of Medicine and Molecular and Cellular Biology
Division of Diabetes, Endocrinology and Metabolism
Baylor College of Medicine and Baylor St. Luke’s Medical Center
Houston, Texas 77030
MedicalResearch.com: What is the background for this study?
Response: The Testosterone Trials are a coordinated set of seven trials to determine the efficacy of testosterone in symptomatic men ≥65 years with unequivocally low testosterone levels. Previous studies in older men have been limited and the results have been conflicting. Initial results of the Sexual Function Trial showed that testosterone improved sexual activity, sexual desire and erectile function.
MedicalResearch.com: What are the main findings?
Response: Compared with placebo, testosterone administration significantly improved 10 of 12 measures of sexual activity. Incremental increases in total and free testosterone and estradiol levels were associated with improvements in sexual activity and desire, but not erectile function. No threshold testosterone level was observed for any outcome, and none of 27 baseline characteristics predicted responsiveness to testosterone.
MedicalResearch.com: What should readers take away from your report?
Response: Older men with low libido and low testosterone levels may experience modest improvements in sexual desire, erectile function and sexual activity when treated with testosterone. Ten of 12 types of sexual activity were improved by testosterone treatment. We did not observe a serum testosterone threshold for these effects.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: It is very important that a large trial be conducted to assess the effects of testosterone treatment on cardiovascular events and clinical prostate cancers. This will require about 5000 men being treated with testosterone or placebo for 3-5 years. In the interim physicians will need to explain the potential benefits and risks of testosterone treatment to men with low testosterone levels and symptoms that are consistent with testosterone deficiency, and it will be necessary to monitor men who choose to receive testosterone treatment for efficacy and potential side effects.
MedicalResearch.com: Is there anything else you would like to add?
Response: The FDA has mandated that pharmaceutical companies conduct a large safety trial. Hopefully, that trial will get started by the end of this year.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
J Clin Endocrinol Metab. 2016 Jun 29:jc20161645. [Epub ahead of print]
Testosterone Treatment and Sexual Function in Older Men with Low Testosterone Levels.
Cunningham GR1, Stephens-Shields AJ1, Rosen RC1, Wang C1, Bhasin S1, Matsumoto AM1, Parsons JK1, Gill TM1, Molitch ME1, Farrar JT1, Cella D1, Barrett-Connor E1, Cauley JA1, Cifelli D1, Crandall JP1, Ensrud KE1, Gallagher L1, Zeldow B1, Lewis CE1, Pahor M1,Swerdloff RS1, Hou X1, Anton S1, Basaria S1, Diem SJ1, Tabatabaie V1, Ellenberg SS1, Snyder PJ1.
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