Cited by 148Hormonal and reproductive studiesMenopause: Health Impacts and TreatmentsSexual function and dysfunction studies

The efficacy and adverse events of testosterone replacement therapy in hypogonadal men: A systematic review and meta-analysis of randomized, placebo-controlled trials

Ponce, Oscar J, Spencer-Bonilla, Gabriela, Alvarez-Villalobos, Neri, Serrano, Valentina, Singh-Ospina, Naykky, Rodriguez-Gutierrez, Rene, Salcido-Montenegro, Alejandro, Benkhadra, Raed +3 more·2018·The Journal of Clinical Endocrinology & Metabolism

Abstract

CONTEXT: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood. OBJECTIVE: To conduct a systematic review and meta-analysis of randomized clinical trials (RCT) to determine the effects of TRT on patient-important outcomes and adverse events in hypogonadal men. DATA SOURCES: We searched Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus from inception to March 2th, 2017. STUDY SELECTION: RCTs that assessed the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning testosterone ≤300 ng/dL and at least one symptom or sign of hypogonadism. DATA EXTRACTION: Reviewers working independently and in duplicate assessed the quality of the trials and collected data on patient characteristics, interventions, and outcomes. DATA SYNTHESIS: We found 11 publications, reporting on 4 eligible trials (including 1,779 patients) at low risk of bias. Compared to placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17, 95% CI 0.01, 0.34] (n=1383), erectile function [SMD: 0.16, 95% CI 0.06, 0.27] (n=1344), and sexual satisfaction [SMD: 0.16, 95% CI 0.01, 0.31] (n=676), but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis [relative risk: 8.14, 95% CI: 1.87, 35.40] (n=1579) compared to placebo, but had no significant effect on lower urinary tract symptoms (LUTS). CONCLUSION: In hypogonadal men TRT improves sexual desire, erectile function, and sexual satisfaction, however it increases the risk of erythrocytosis.

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Crossref · 10.1210/jc.2018-00404

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Authors
Ponce, O. J., Spencer-Bonilla, G., Alvarez-Villalobos, N., Serrano, V., Singh-Ospina, N., Rodriguez-Gutierrez, R., Salcido-Montenegro, A., Benkhadra, R., Prokop, L. J., Bhasin, S., & Brito, J. P.
Affiliations
  • Mayo Clinic (US)
  • Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, Minnesota
  • Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario “Dr. José E. Gonzalez,” Plataforma INVEST-KER Mexico, Monterrey, Nuevo León, México
  • Brigham and Women's Hospital (US)
Corresponding author
Brito, Juan P
Venue
The Journal of Clinical Endocrinology & Metabolism
Published
2018-03-17
Volume
103
Issue
5
Pages
1745-1754
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
OpenAlex
W2792321631
Cited by
148
References
39
Citations by year
2026: 11 · 2025: 13 · 2024: 12 · 2023: 18 · 2022: 24 · 2021: 22 · 2020: 14 · 2019: 20 · 2018: 13
FWCI
2.65
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Keywords
testosterone replacement therapy, male hypogonadism, sexual desire, erectile function, sexual satisfaction, erythrocytosis, lower urinary tract symptoms, adverse events

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