Hypogonadism in men

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Última revisão: 21 Jul 2025

Última atualização: 04 Jul 2025

04 Jul 2025

Evidence supports cardiovascular safety of testosterone therapy in men with hypogonadism

High-quality evidence suggests that testosterone therapy does not increase cardiovascular risk in men with hypogonadism.

A large clinical trial (the TRAVERSE trial) reported that testosterone therapy is noninferior to placebo for incidence of major adverse cardiovascular events in men with hypogonadism and preexisting cardiovascular disease, or at high risk for cardiovascular disease.[61] Mean treatment duration was 21.7 months. In addition, systematic reviews and meta-analyses found no evidence that testosterone increases short-term to medium-term cardiovascular risks in men with hypogonadism.[62][63]

These findings led the US Food and Drug Administration (FDA) to update its safety information for all testosterone products, including the removal of a boxed warning stating that testosterone therapy increases the risk of major adverse cardiovascular outcomes.[64] The results of the TRAVERSE trial will be added to the labels of testosterone products in the US. The FDA have, however, added new information about the risk of increased blood pressure to testosterone product labels.

Clinicians should:

Discuss the risks and benefits of testosterone therapy with patients before starting treatment.
Reassure patients that testosterone therapy for hypogonadism will not increase their risk of heart attack or stroke.
Regularly monitor blood pressure in patients taking testosterone therapy.

These changes update prior safety warnings for testosterone products, including a 2014 warning on the reported risks of stroke, heart attack, and death in men taking these products.

Information about the “limitation of use” for age-related low testosterone has been retained.

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Fonte original da atualização

Hypogonadism in men may present with reproductive/sexual clinical features (e.g., incomplete pubertal development, subfertility, gynecomastia), as well as nonreproductive features (e.g., fatigue, anemia, osteoporosis, loss of motivation or concentration, irritability, low or labile mood, body image concerns).

Patients may have additional symptoms due to mass effects when hypogonadism is caused by large parasellar lesions (e.g., headache, peripheral visual disturbance), or may have signs or symptoms of other hormone deficiencies.

Early morning fasting serum total testosterone level <300 nanograms/dL on at least two separate occasions in a man with one or more clinical features confers the diagnosis of hypogonadism in most cases.

Measurement of the gonadotropins (luteinizing hormone [LH], follicle-stimulating hormone [FSH]) distinguishes between a primary cause (dysfunction of the testes) and a secondary (also known as central or hypogonadotropic) cause (pituitary or hypothalamic dysfunction).

Management of men with low testosterone due to nongonadal illness (e.g., obesity) is to optimize treatment of the underlying condition.

Testosterone therapy is used to achieve normal physiologic serum testosterone levels, with dose adjustment to maximum effect on relevant clinical features (without causing erythrocytosis).

Definição

Hypogonadism in males is a clinical syndrome that comprises symptoms and/or signs, along with biochemical evidence of testosterone deficiency. It is usually associated with subfertility.[1][2]

The male gonads (testes) have two primary functions: testosterone production (by the Leydig cells) and spermatogenesis (by the spermatogenic and Sertoli cells in the seminiferous tubules). Hypogonadism in men occurs where there is dysfunction in the normal physiologic mechanism of the hypothalamic-pituitary-gonadal axis that results in a decreased ability to carry out either of these functions.

História e exame físico

Principais fatores diagnósticos

decreased libido
loss of spontaneous morning erections
erectile dysfunction
normocytic anemia
gynecomastia
subfertility
micropenis
small testes
bifid or hypoplastic scrotum
cryptorchidism, especially if bilateral
segmental dysproportion
bitemporal hemianopia
low trauma fractures
loss of height
anosmia

Detalhes completos

Outros fatores diagnósticos

decreased energy and fatigue
absent or incomplete puberty
scrotal hypoplasia, hypopigmentation, and absent rugae
decreased muscle mass and strength
loss of axillary and pubic hair
lack of facial hair
poor concentration and memory
depressed or labile mood
sleep disturbance
hot flashes and sweats
tall stature
fine wrinkling of facial skin

Detalhes completos

Fatores de risco

genetic anomaly
type 2 diabetes mellitus
use of alkylating agents, opioids, or glucocorticoids
use of exogenous sex hormones and GnRH analogs
hyperprolactinemia
parasellar tumor or apoplexy of pituitary macroadenoma
testicular damage
infection
varicocele

Detalhes completos

Investigações diagnósticas

Primeiras investigações a serem solicitadas

serum total testosterone

Detalhes completos

Investigações a serem consideradas

serum sex hormone-binding globulin (SHBG)
calculated free testosterone
serum LH/FSH
semen analysis
CBC
serum prolactin
serum transferrin saturation and ferritin
MRI pituitary
genetic testing
dual-energy x-ray absorptiometry (DEXA or DXA)

Detalhes completos

Algoritmo de tratamento

CONTÍNUA

nongonadal illness

not desiring fertility currently: primary hypogonadism

not desiring fertility currently: secondary hypogonadism

desiring fertility currently: primary hypogonadism

desiring fertility currently: secondary hypogonadism

Colaboradores

Autores

Richard Quinton, MD FRCP(Edin)

Consultant Endocrinologist

Northern Region Gender Dysphoria Service

Tyne & Wear NHS Foundation Trust

Newcastle upon Tyne

Honorary Reader in Reproductive Endocrinology

Department of Metabolism, Digestion and Reproduction

Imperial College London

Declarações

RQ has received speaker fees and an advisory board fee from Besins Healthcare UK, speaker fees from Androlabs, and was on an advisory board for Roche Diagnostics. RQ is an author of several references cited in this topic.

Channa N. Jayasena, PhD FRCP FRCPath

Consultant and Reader in Reproductive Endocrinology/Andrology

Department of Investigative Medicine

Hammersmith Hospital

Imperial College London

London

Declarações

CNJ has an investigator-led research grant from LogixX Pharma Ltd. CNJ is supported by a National Institute for Health Research (NIHR) Post-Doctoral Fellowship. CNJ is an author of several references cited in this topic.

Agradecimentos

Dr Richard Quinton and Dr Channa N. Jayasena would like to gratefully acknowledge Dr Charles Welliver, Dr T. Hugh Jones, Dr Milena Braga-Basaria, and Dr Shehzad Basaria, previous contributors to this topic.

Declarações

CW has worked as a consultant for Coloplast, and as an investigator for Auxilium Pharmaceuticals, Mereo BioPharma, PROCEPT BioRobotics, and Repros; and he is a paid reviewer at Oakstone Publishing and BMJ Best Practice. CW also has a family member who is an employee at Bristol-Myers Squibb. THJ and SB are authors of references cited in this topic. MB declared that she had no competing interests.

Revisores

Randal J. Urban, MD

Professor

Department of Internal Medicine

University of Texas Medical Branch

Galveston

Declarações

RJU declares that he has no competing interests.

Niki Karavitaki, MBBS, MSc, PhD

Consultant Endocrinologist

Oxford Centre for Diabetes, Endocrinology and Metabolism

Churchill Hospital

Oxford

Declarações

NK declares that she has no competing interests.

Referências

Nossas equipes internas de editoria e de evidências trabalham em conjunto com colaboradores internacionais especializados e pares revisores para garantir que forneçamos acesso às informações o mais clinicamente relevantes possível.

Principais artigos

Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol. 2018 Aug;200(2):423-32.Texto completo Resumo

Jayasena CN, Anderson RA, Llahana S, et al. Society for Endocrinology guidelines for testosterone replacement therapy in male hypogonadism. Clin Endocrinol (Oxf). 2022 Feb;96(2):200-19.Texto completo Resumo

Matsumoto AM. Diagnosis and evaluation of hypogonadism. Endocrinol Metab Clin North Am. 2022 Mar;51(1):47-62. Resumo

Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018 May 1;103(5):1715-44.Texto completo Resumo

Artigos de referência

Uma lista completa das fontes referenciadas neste tópico está disponível para os usuários com acesso total ao BMJ Best Practice.

Diagnósticos diferenciais
- Klinefelter syndrome
- Pituitary macroadenoma
- Prolactinoma
Mais Diagnósticos diferenciais
Diretrizes
- Hormones and aging: an Endocrine Society scientific statement
- Evaluation and management of testosterone deficiency: AUA guideline
Mais Diretrizes
Folhetos informativos para os pacientes
Erection problems
Fertility problems: some reasons
Mais Folhetos informativos para os pacientes
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Hypogonadism in men

​Evidence supports cardiovascular safety of testosterone therapy in men with hypogonadism

Resumo

Definição

História e exame físico

Principais fatores diagnósticos

Outros fatores diagnósticos

Fatores de risco

Investigações diagnósticas

Primeiras investigações a serem solicitadas

Investigações a serem consideradas

Algoritmo de tratamento

nongonadal illness

not desiring fertility currently: primary hypogonadism

not desiring fertility currently: secondary hypogonadism

desiring fertility currently: primary hypogonadism

desiring fertility currently: secondary hypogonadism

Colaboradores

Autores

Richard Quinton, MD FRCP(Edin)

Declarações

Channa N. Jayasena, PhD FRCP FRCPath

Declarações

Agradecimentos

Declarações

Revisores

Randal J. Urban, MD

Declarações

Niki Karavitaki, MBBS, MSc, PhD

Declarações

Referências

Principais artigos

Artigos de referência

Uma lista completa das fontes referenciadas neste tópico está disponível para os usuários com acesso total ao BMJ Best Practice.

Diagnósticos diferenciais

Diretrizes

Folhetos informativos para os pacientes

Conectar-se ou assinar para acessar todo o BMJ Best Practice

Conectar-se ou assinar para acessar todo o BMJ Best Practice

Conectar-se para acessar todo o BMJ Best Practice

Evidence supports cardiovascular safety of testosterone therapy in men with hypogonadism