Male Hypogonadism

Diagnose male hypogonadism only when symptoms or signs consistent with androgen deficiency coexist with unequivocally and consistently low serum total testosterone and/or free testosterone when indicated. Do not screen the general male population routinely. endocrine+1endocrineTestosterone Therapy for Hypogonadism Guideline Resources | Endocrine Societyendocrine[PDF] Endocrine Society Testimony to the

Obtain total testosterone on at least two separate early-morning samples, preferably before 10 AM; one commonly used biochemical threshold is total testosterone below 300 ng/dL, but interpret results against the reporting laboratory reference interval. A fasting early-morning total testosterone below 300 ng/dL on two occasions in a symptomatic man supports the diagnosis in most cases. BMJ+1BMJHypogonadism in men - Symptoms, diagnosis and treatment | BMJ Best PracticejaccTestosterone and Cardiovascular Disease - JACC

Order free testosterone when altered sex hormone-binding globulin may make total testosterone misleading: total testosterone may be low with reduced SHBG in obesity or diabetes and may be elevated with increased SHBG during aging. A discordant total testosterone result should therefore prompt free-testosterone assessment rather than empiric replacement. jaccjaccTestosterone and Cardiovascular Disease - JACC

After confirming low testosterone, measure LH and FSH to distinguish primary from secondary hypogonadism. Elevated gonadotropins with low testosterone reflect impaired testicular testosterone production; low or normal gonadotropins with low testosterone are inappropriately low and indicate hypothalamic-pituitary dysfunction. dailymed nlm nih+2dailymed nlm nihThese highlights do not include all the information needed to use TESTOSTERONE GEL, 1% safely and effectively. See full prescribing information for TESTOSTERONE GEL, 1%. TESTOSTERONE gel 1%, for topical use, CIII Initial U.S. Approval: 1953jaccTestosterone and Cardiovascular Disease - JACCendocrineTestosterone Therapy for Hypogonadism Guideline Resources | Endocrine Society

For primary hypogonadism, target the history and examination to testicular failure. FDA labeling identifies cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, and toxic injury from alcohol or heavy metals as causes. Klinefelter syndrome classically presents with tall stature, relatively long legs, small firm testes, gynecomastia, azoospermia, and progressive hypogonadism; confirm suspected cases with karyotype testing. dailymed nlm nih+1dailymed nlm nihThese highlights do not include all the information needed to use TESTOSTERONE GEL, 1% safely and effectively. See full prescribing information for TESTOSTERONE GEL, 1%. TESTOSTERONE gel 1%, for topical use, CIII Initial U.S. Approval: 1953ScienceDirectKlinefelter syndrome: more than hypogonadism

For secondary hypogonadism, ask specifically about pituitary tumor, head trauma, cranial irradiation, and congenital GnRH deficiency. Obtain serum prolactin if a pituitary tumor is a concern; suspected hypogonadotropic hypogonadism or pituitary disease is an indication for pituitary MRI. dailymed nlm nih+2dailymed nlm nihThese highlights do not include all the information needed to use TESTOSTERONE GEL, 1% safely and effectively. See full prescribing information for TESTOSTERONE GEL, 1%. TESTOSTERONE gel 1%, for topical use, CIII Initial U.S. Approval: 1953jaccTestosterone and Cardiovascular Disease - JACCWileyManagement of Azoospermia: A Systematic Approach - Raza - 2026

In men with congenital hypogonadotropic hypogonadism, delayed or arrested puberty is the usual presentation. In infancy, cryptorchidism with or without micropenis should trigger consideration of congenital hypogonadotropic hypogonadism, with gonadotropin and sex-steroid profiling at 4 to 8 weeks during mini-puberty. NatureNatureEuropean Consensus Statement on congenital hypogonadotropic ...

Offer testosterone therapy to men with confirmed hypogonadism to induce and maintain secondary sexual characteristics and correct manifestations of testosterone deficiency. FDA-approved products are indicated for males with low testosterone associated with primary or hypogonadotropic hypogonadism and are not approved solely for age-related testosterone decline. accessdata fda+2accessdata fda[PDF] 202763Orig1s000 | FDA - accessdata.fda.govfdaFDA issues class-wide labeling changes for testosterone products | FDAendocrineTestosterone Therapy for Hypogonadism Guideline Resources | Endocrine Society

Before prescribing, establish reproductive intent. Exogenous testosterone suppresses spermatogenesis and can produce azoospermia; it is therefore inappropriate for men actively seeking fertility. In persistent central hypogonadism after prolactinoma treatment, use gonadotropin treatment when fertility is desired. accessdata fda+2accessdata fda[PDF] Risk Assessment adn Risk Mitigation Review(s) - accessdata.fda.govdailymed nlm nihThese highlights do not include all the information needed to use TESTOSTERONE GEL, 1% safely and effectively. See full prescribing information for TESTOSTERONE GEL, 1%. TESTOSTERONE gel 1%, for topical use, CIII Initial U.S. Approval: 1953NatureDiagnosis and management of prolactin-secreting pituitary adenomas

Choose formulation based on adherence, route preference, exposure risk, and monitoring. Available U.S. testosterone formulations include injections, topical gels and solutions, patches, buccal systems, nasal gel, implantable pellets, and oral products. Topical products can cause local irritation and create transfer risk; nasal formulations require three-times-daily dosing. accessdata fda+1accessdata fda[PDF] Risk Assessment adn Risk Mitigation Review(s) - accessdata.fda.govfdaFDA issues class-wide labeling changes for testosterone products | FDA

For testosterone gel 1%, the labeled adult starting dose is 50 mg applied topically once daily. Do not interchange topical products by milligram dose because strengths, application instructions, and systemic exposure differ among products. accessdata fdaaccessdata fda[PDF] 202763Orig1s000 | FDA - accessdata.fda.gov

For weekly subcutaneous testosterone enanthate, FDA-reviewed dosing is 50 mg, 75 mg, or 100 mg once weekly. Select a formulation only after ensuring that the patient can follow route-specific administration and monitoring requirements. accessdata fdaaccessdata fda[PDF] Risk Assessment adn Risk Mitigation Review(s) - accessdata.fda.gov

Adjust testosterone therapy to achieve physiologic serum testosterone concentrations and improve relevant clinical features without inducing erythrocytosis. Testosterone products can increase hematocrit and PSA; monitor these parameters during treatment. accessdata fda+1accessdata fda[PDF] Risk Assessment adn Risk Mitigation Review(s) - accessdata.fda.govBMJHypogonadism in men - Symptoms, diagnosis and treatment | BMJ Best Practice

During the first 12 months, obtain urologic consultation for a confirmed PSA increase greater than 1.4 ng/mL above baseline, a confirmed PSA greater than 4.0 ng/mL, or a prostatic abnormality on digital rectal examination. After 1 year, follow standard prostate-cancer screening guidance based on age and race. endocrineendocrineTestosterone Therapy for Hypogonadism Guideline Resources | Endocrine Society

Assess for treatment-related edema, particularly in men with pre-existing cardiac, renal, or hepatic disease because androgens can promote sodium and water retention and may cause serious edema with or without congestive heart failure. Ask about sleep-apnea worsening in patients with baseline risk factors and evaluate persistent gynecomastia. accessdata fda+1accessdata fda[PDF] Risk Assessment adn Risk Mitigation Review(s) - accessdata.fda.govaccessdata fda[PDF] 202763Orig1s000 | FDA - accessdata.fda.gov

FDA’s 2025 class-wide review incorporated TRAVERSE findings showing no increase in major adverse cardiovascular outcomes in men using testosterone for hypogonadism. FDA also required class-wide labeling changes based on ambulatory blood-pressure studies; account for blood-pressure risk during treatment surveillance. fdafdaFDA issues class-wide labeling changes for testosterone products | FDA