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

doi:10.1210/jc.2016-1645

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 Cunningham¹, Alisa J Stephens-Shields¹, Raymond C Rosen¹, Christina Wang¹, Shalender Bhasin¹, Alvin M Matsumoto¹, J Kellogg Parsons¹, Thomas M Gill¹, Mark E Molitch¹, John T Farrar¹, David Cella¹, Elizabeth Barrett-Connor¹, Jane A Cauley¹, Denise Cifelli¹, Jill P Crandall¹, Kristine E Ensrud¹, Laura Gallagher¹, Bret Zeldow¹, Cora E Lewis¹, Marco Pahor¹, Ronald S Swerdloff¹, Xiaoling Hou¹, Stephen Anton¹, Shehzad Basaria¹, Susan J Diem¹, Vafa Tabatabaie¹, Susan S Ellenberg¹, Peter J Snyder¹

Affiliations

Affiliation

¹ Departments of Medicine and Molecular and Cellular Biology (G.R.C.), Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas 77030; Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., B.Z., X.H., S.S.E.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; New England Research Institutes, Inc (R.C.R.), Watertown, Massachusetts 02472; Division of Endocrinology (C.W., R.S.S.), Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90502; Research Program in Men's Health: Aging and Metabolism (S.Bh., S.Ba.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Geriatric Research, Education, and Clinical Center (A.M.M.), Department of Veterans Affairs Puget Sound Health Care System, and Division of Gerontology & Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington 98108-1597; Department of Urology (J.K.P.), Moores Comprehensive Cancer Center, University of California, San Diego, California 92093; Division of Geriatric Medicine (T.M.G.), Yale School of Medicine, New Haven, Connecticut 06510; Division of Endocrinology, Metabolism, and Molecular Medicine (M.E.M.), and Department of Medical Social Sciences (D.C.), Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611; Division of Epidemiology (E.B.-C.), Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, California 92093-0607; Department of Epidemiology (J.A.C.), University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania 15261; Center for Clinical Epidemiology and Biostatistics (D.C., L.G.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; Divisions of Endocrinology and Geriatrics (

PMID: 27355400
PMCID: PMC4971331
DOI: 10.1210/jc.2016-1645

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.

. 2016 Aug;101(8):3096-104.

doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.

Authors

Affiliation

¹ Departments of Medicine and Molecular and Cellular Biology (G.R.C.), Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas 77030; Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., B.Z., X.H., S.S.E.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; New England Research Institutes, Inc (R.C.R.), Watertown, Massachusetts 02472; Division of Endocrinology (C.W., R.S.S.), Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance, California 90502; Research Program in Men's Health: Aging and Metabolism (S.Bh., S.Ba.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Geriatric Research, Education, and Clinical Center (A.M.M.), Department of Veterans Affairs Puget Sound Health Care System, and Division of Gerontology & Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington 98108-1597; Department of Urology (J.K.P.), Moores Comprehensive Cancer Center, University of California, San Diego, California 92093; Division of Geriatric Medicine (T.M.G.), Yale School of Medicine, New Haven, Connecticut 06510; Division of Endocrinology, Metabolism, and Molecular Medicine (M.E.M.), and Department of Medical Social Sciences (D.C.), Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611; Division of Epidemiology (E.B.-C.), Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, California 92093-0607; Department of Epidemiology (J.A.C.), University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania 15261; Center for Clinical Epidemiology and Biostatistics (D.C., L.G.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; Divisions of Endocrinology and Geriatrics (

PMID: 27355400
PMCID: PMC4971331
DOI: 10.1210/jc.2016-1645

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.**
Total (A) and free (B) T, estradiol (C), and SHBG (D) levels at baseline and during treatment.

**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

Re: Testosterone Treatment and Sexual Function in Older Men with Low Testosterone Levels.
Seftel AD. Seftel AD. J Urol. 2016 Dec;196(6):1721-1724. doi: 10.1016/j.juro.2016.09.058. Epub 2016 Oct 21. J Urol. 2016. PMID: 27845126 No abstract available.
Re: Testosterone Treatment and Sexual Function in Older Men with Low Testosterone Levels.
Griebling TL. Griebling TL. J Urol. 2017 Feb;197(2):495. doi: 10.1016/j.juro.2016.11.050. Epub 2016 Nov 15. J Urol. 2017. PMID: 28093177 No abstract available.

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References

1. Burris AS, Banks SM, Carter CS, Davidson JM, Sherins RJ. A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J Androl. 1992;13(4):297–304. - PubMed
1. Snyder PJ, Peachey H, Berlin JA, et al. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2670–2677. - PubMed
1. Bhasin S, Woodhouse L, Casaburi R, et al. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001;281(6):E1172–E1181. - PubMed
1. Finkelstein JS, Yu EW, Burnett-Bowie SA. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013;369(25):2457. - PubMed
1. Bagatell CJ, Heiman JR, Rivier JE, Bremner WJ. Effects of endogenous testosterone and estradiol on sexual behavior in normal young men. J Clin Endocrinol Metab. 1994;78(3):711–716. - PubMed

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[1] Burris AS, Banks SM, Carter CS, Davidson JM, Sherins RJ. A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J Androl. 1992;13(4):297–304. - PubMed

[2] Burris AS, Banks SM, Carter CS, Davidson JM, Sherins RJ. A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J Androl. 1992;13(4):297–304. - PubMed

[3] Snyder PJ, Peachey H, Berlin JA, et al. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2670–2677. - PubMed

[4] Snyder PJ, Peachey H, Berlin JA, et al. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2670–2677. - PubMed

[5] Bhasin S, Woodhouse L, Casaburi R, et al. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001;281(6):E1172–E1181. - PubMed

[6] Bhasin S, Woodhouse L, Casaburi R, et al. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001;281(6):E1172–E1181. - PubMed

[7] Finkelstein JS, Yu EW, Burnett-Bowie SA. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013;369(25):2457. - PubMed

[8] Finkelstein JS, Yu EW, Burnett-Bowie SA. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013;369(25):2457. - PubMed

[9] Bagatell CJ, Heiman JR, Rivier JE, Bremner WJ. Effects of endogenous testosterone and estradiol on sexual behavior in normal young men. J Clin Endocrinol Metab. 1994;78(3):711–716. - PubMed

[10] Bagatell CJ, Heiman JR, Rivier JE, Bremner WJ. Effects of endogenous testosterone and estradiol on sexual behavior in normal young men. J Clin Endocrinol Metab. 1994;78(3):711–716. - PubMed

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

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