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Randomized Controlled Trial
. 2016 Aug;101(8):3096-104.
doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.

Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels

Glenn R Cunningham  1 , Alisa J Stephens-Shields  1 , Raymond C Rosen  1 , Christina Wang  1 , Shalender Bhasin  1 , Alvin M Matsumoto  1 , J Kellogg Parsons  1 , Thomas M Gill  1 , Mark E Molitch  1 , John T Farrar  1 , David Cella  1 , Elizabeth Barrett-Connor  1 , Jane A Cauley  1 , Denise Cifelli  1 , Jill P Crandall  1 , Kristine E Ensrud  1 , Laura Gallagher  1 , Bret Zeldow  1 , Cora E Lewis  1 , Marco Pahor  1 , Ronald S Swerdloff  1 , Xiaoling Hou  1 , Stephen Anton  1 , Shehzad Basaria  1 , Susan J Diem  1 , Vafa Tabatabaie  1 , Susan S Ellenberg  1 , Peter J Snyder  1
Affiliations
Randomized Controlled Trial

Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels

Glenn R Cunningham et al. J Clin Endocrinol Metab. 2016 Aug.

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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Figures

Figure 1.
Figure 1.
Total (A) and free (B) T, estradiol (C), and SHBG (D) levels at baseline and during treatment.
Figure 2.
Figure 2.
A, Forest plots showing the effect of treatment on each item of the PDQ-Q4. B, Average daily frequency of each item of the PDQ-Q4 by treatment group.
See this image and copyright information in PMC

Comment in

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