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

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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, Prokop, Larry J, Bhasin, Shalender, Brito, Juan P·2018·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2018-00404

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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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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
ORCID: Ponce, Oscar J
Prokop, Larry J
Bhasin, Shalender
Brito, Juan P
Venue: The Journal of Clinical Endocrinology & Metabolism
Publisher: The Endocrine Society
Published: 2018-03-17
Volume: 103
Issue: 5
Pages: 1745-1754
ISSN: 0021-972X (ISSN-L)
1945-7197
DOI: 10.1210/jc.2018-00404
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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The Efficacy and Adverse Events of Testosterone Replacement Therapy in Hypogonadal Men: A Systematic Review and Meta-Analysis of Randomized, Placebo-Controlled Trials

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