Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels
Glenn R Cunningham, Alisa J Stephens-Shields, Raymond C Rosen, Christina Wang, Shalender Bhasin, Alvin M Matsumoto, J Kellogg Parsons, Thomas M Gill, Mark E Molitch, John T Farrar, David Cella, Elizabeth Barrett-Connor, Jane A Cauley, Denise Cifelli, Jill P Crandall, Kristine E Ensrud, Laura Gallagher, Bret Zeldow, Cora E Lewis, Marco Pahor, Ronald S Swerdloff, Xiaoling Hou, Stephen Anton, Shehzad Basaria, Susan J Diem, Vafa Tabatabaie, Susan S Ellenberg, Peter J Snyder, Glenn R Cunningham, Alisa J Stephens-Shields, Raymond C Rosen, Christina Wang, Shalender Bhasin, Alvin M Matsumoto, J Kellogg Parsons, Thomas M Gill, Mark E Molitch, John T Farrar, David Cella, Elizabeth Barrett-Connor, Jane A Cauley, Denise Cifelli, Jill P Crandall, Kristine E Ensrud, Laura Gallagher, Bret Zeldow, Cora E Lewis, Marco Pahor, Ronald S Swerdloff, Xiaoling Hou, Stephen Anton, Shehzad Basaria, Susan J Diem, Vafa Tabatabaie, Susan S Ellenberg, Peter J Snyder
Abstract
Context: The Testosterone Trials are a coordinated set of seven trials to determine the efficacy of T in symptomatic men ≥65 years old with unequivocally low T levels. Initial results of the Sexual Function Trial showed that T improved sexual activity, sexual desire, and erectile function.
Objective: To assess the responsiveness of specific sexual activities to T treatment; to relate hormone changes to changes in sexual function; and to determine predictive baseline characteristics and T threshold for sexual outcomes.
Design: A placebo-controlled trial.
Setting: Twelve academic medical centers in the United States.
Participants: A total of 470 men ≥65 years of age with low libido, average T <275 ng/dL, and a partner willing to have sexual intercourse at least twice a month.
Methods: Men were assigned to take T gel or placebo for 1 year. Sexual function was assessed by three questionnaires every 3 months: the Psychosexual Daily Questionnaire, the Derogatis Interview for Sexual Function, and the International Index of Erectile Function.
Results: Compared with placebo, T administration significantly improved 10 of 12 measures of sexual activity. Incremental increases in total and free T and estradiol levels were associated with improvements in sexual activity and desire, but not erectile function. No threshold T level was observed for any outcome, and none of the 27 baseline characteristics predicted responsiveness to T.
Conclusions: In older men with low libido and low T levels, improvements in sexual desire and activity in response to T treatment were related to the magnitude of increases in T and estradiol levels, but there was no clear evidence of a threshold effect.
Trial registration: ClinicalTrials.gov NCT00799617.
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Source: PubMed