Why Is Androgen Replacement in Males Controversial?
Abstract
Context: Symptoms and signs consistent with androgen deficiency and low testosterone levels are recognized frequently in clinical practice. Recent population-based epidemiological studies indicate that low testosterone levels in men are associated with increased morbidity and mortality. The clinician must be able to counsel patients to help them determine whether testosterone replacement therapy is appropriate for them. Evidence Acquisition: The authors have conducted a literature search in PubMed, and we have reviewed references in the multiple systematic reviews and meta-analyses that have been published on this topic. Evidence Synthesis: We have attempted to provide the reader with an appreciation of the evidence that can be used to support the diagnosis of androgen deficiency, the efficacy of treatment, the potential risks of treatment, the therapeutic options, and the recommendations for monitoring treatment. Conclusions: We think that published clinical experience justifies testosterone replacement therapy in males who have not initiated puberty by age 14 and in males with low testosterone levels due to classical diseases of the hypothalamic-pituitary-gonadal axis. The benefit:risk ratio is less certain in older men and in those with chronic diseases associated with low testosterone levels. The decision to treat in this setting is much more controversial because there are few large clinical trials that have demonstrated efficacy and no large clinical trials that have determined potential risks of increasing the incidence of clinical prostate cancers or cardiovascular events. We provide a critical review of the evidence that supports treatment and potential risks and ways to reduce the risks if the physician and patient elect testosterone replacement.
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A verdict on treating elderly men with lower than normal testosterone levels can only be reached with large-scale studies including 5000 men over 5 years.
“a verdict can only be reached with large-scale studies including 5000 men over 5 years (95)”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [95]
It is still hotly debated whether late-onset hypogonadism is a true form of hypogonadism or a decline of serum testosterone associated with the progressive accumulation of health problems with aging, rather independently of the process of aging itself.
“It is still hotly debated whether this is a true form of hypogonadism, or a decline of serum testosterone associated with the progressive accumulation of health problems with aging (95, 96), but rather independently of the process of aging itself.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [95]
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- Authors
- Cunningham, G. R., & Toma, S. M.
- Affiliations
- Baylor St. Luke's Medical Center (US)
- Corresponding author
- Cunningham, Glenn R.
- ORCID
- Cunningham, Glenn R.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2011-01-01
- Volume
- 96
- Issue
- 1
- Pages
- 38-52
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2129345748
- Cited by
- 111
- References
- 146
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 3 · 2023: 3 · 2022: 1 · 2021: 2 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 4 · 2016: 10 · 2015: 11 · 2014: 17 · 2013: 23 · 2012: 17
- FWCI
- 2.37
- 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 › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone replacement therapy, male hypogonadism, androgen deficiency, risk-benefit assessment, prostate cancer risk, cardiovascular risk, hypothalamic-pituitary-gonadal axis, treatment monitoring, older men, chronic disease
- MeSH terms
- Androgens, Humans, Hypogonadism, Male, Hormone Replacement Therapy
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