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

doi:10.1210/jc.2016-1645

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 PahorRonald S. Swerdloff, Xiaoling Hou, Stephen Anton, Shehzad Basaria, Susan J. Diem, Vafa Tabatabaie, Susan S. Ellenberg, Peter J. Snyder

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

119 Scopus citations

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 activityanddesire, but not erectile function.Nothreshold T levelwasobserved 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.

Original language	English (US)
Pages (from-to)	3096-3104
Number of pages	9
Journal	Journal of Clinical Endocrinology and Metabolism
Volume	101
Issue number	8
DOIs	https://doi.org/10.1210/jc.2016-1645
State	Published - Aug 2016

Bibliographical note

Funding Information:
The Testosterone Trials were supported by a grant from the National Institute on Aging (NIA), National Institutes of Health (NIH) (U01 AG030644), supplemented by funds from the National Heart, Lung, and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) generously provided funding, AndroGel and placebo gel. C.W. reports funding from CTSI (UL1TR000124). The Boston site was supported partly by the Boston Claude D. Pepper Older Americans Independence Center. A.M.M. was supported by the Department of Veterans Affairs Puget Sound Health Care System. T.M.G. is the recipient of an Academic Leadership Award (K24-AG021507) from the NIA. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and Yale CTSA (UL1 TR000142). C.E.L. was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, NIH

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Cunningham, G. R., Stephens-Shields, A. J., Rosen, R. C., Wang, C., Bhasin, S., Matsumoto, A. M., Parsons, J. K., Gill, T. M., Molitch, M. E., Farrar, J. T., Cella, D., Barrett-Connor, E., Cauley, J. A., Cifelli, D., Crandall, J. P., Ensrud, K. E., Gallagher, L., Zeldow, B., Lewis, C. E., ... Snyder, P. J. (2016). Testosterone treatment and sexual function in older men with low testosterone levels. Journal of Clinical Endocrinology and Metabolism, 101(8), 3096-3104. https://doi.org/10.1210/jc.2016-1645

Cunningham, GR, Stephens-Shields, AJ, Rosen, RC, Wang, C, Bhasin, S, Matsumoto, AM, Parsons, JK, Gill, TM, Molitch, ME, Farrar, JT, Cella, D, Barrett-Connor, E, Cauley, JA, Cifelli, D, Crandall, JP, Ensrud, KE, Gallagher, L, Zeldow, B, Lewis, CE, Pahor, M, Swerdloff, RS, Hou, X, Anton, S, Basaria, S, Diem, SJ, Tabatabaie, V, Ellenberg, SS & Snyder, PJ 2016, 'Testosterone treatment and sexual function in older men with low testosterone levels', Journal of Clinical Endocrinology and Metabolism, vol. 101, no. 8, pp. 3096-3104. https://doi.org/10.1210/jc.2016-1645

@article{6c27e3e593f647be94078c92a614fe26,

title = "Testosterone treatment and sexual function in older men with low testosterone levels",

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 activityanddesire, but not erectile function.Nothreshold T levelwasobserved 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.",

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

note = "Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging (NIA), National Institutes of Health (NIH) (U01 AG030644), supplemented by funds from the National Heart, Lung, and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) generously provided funding, AndroGel and placebo gel. C.W. reports funding from CTSI (UL1TR000124). The Boston site was supported partly by the Boston Claude D. Pepper Older Americans Independence Center. A.M.M. was supported by the Department of Veterans Affairs Puget Sound Health Care System. T.M.G. is the recipient of an Academic Leadership Award (K24-AG021507) from the NIA. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and Yale CTSA (UL1 TR000142). C.E.L. was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, NIH",

year = "2016",

month = aug,

doi = "10.1210/jc.2016-1645",

language = "English (US)",

volume = "101",

pages = "3096--3104",

journal = "Journal of Clinical Endocrinology and Metabolism",

issn = "0021-972X",

publisher = "Endocrine Society",

number = "8",

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TY - JOUR

T1 - Testosterone treatment and sexual function in older men with low testosterone levels

AU - Cunningham, Glenn R.

AU - Stephens-Shields, Alisa J.

AU - Rosen, Raymond C.

AU - Wang, Christina

AU - Bhasin, Shalender

AU - Matsumoto, Alvin M.

AU - Parsons, J. Kellogg

AU - Gill, Thomas M.

AU - Molitch, Mark E.

AU - Farrar, John T.

AU - Cella, David

AU - Barrett-Connor, Elizabeth

AU - Cauley, Jane A.

AU - Cifelli, Denise

AU - Crandall, Jill P.

AU - Ensrud, Kristine E.

AU - Gallagher, Laura

AU - Zeldow, Bret

AU - Lewis, Cora E.

AU - Pahor, Marco

AU - Swerdloff, Ronald S.

AU - Hou, Xiaoling

AU - Anton, Stephen

AU - Basaria, Shehzad

AU - Diem, Susan J.

AU - Tabatabaie, Vafa

AU - Ellenberg, Susan S.

AU - Snyder, Peter J.

N1 - Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging (NIA), National Institutes of Health (NIH) (U01 AG030644), supplemented by funds from the National Heart, Lung, and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) generously provided funding, AndroGel and placebo gel. C.W. reports funding from CTSI (UL1TR000124). The Boston site was supported partly by the Boston Claude D. Pepper Older Americans Independence Center. A.M.M. was supported by the Department of Veterans Affairs Puget Sound Health Care System. T.M.G. is the recipient of an Academic Leadership Award (K24-AG021507) from the NIA. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and Yale CTSA (UL1 TR000142). C.E.L. was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, NIH

PY - 2016/8

Y1 - 2016/8

N2 - 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 activityanddesire, but not erectile function.Nothreshold T levelwasobserved 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.

AB - 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 activityanddesire, but not erectile function.Nothreshold T levelwasobserved 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.

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Testosterone treatment and sexual function in older men with low testosterone levels

Abstract

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