Testosterone Cypionate in Men 65 and Older: Transition to Adult Care

Is testosterone cypionate approved for men 65 and older?

Testosterone cypionate injection is FDA-approved for replacement therapy in men with primary hypogonadism from testicular failure or hypogonadotropic hypogonadism from pituitary or hypothalamic disease [1]. The Depo-Testosterone label says safety and efficacy in men with age-related hypogonadism have not been established [1]. FDA's testosterone page says none of the approved testosterone products are approved for men with low testosterone who lack an associated medical condition [2].

In February 2025, FDA called for TRAVERSE results and updated blood pressure information to be added to testosterone labels [6]. The Depo-Testosterone label does not mention TRAVERSE [1]. In June 2026 FDA requested further label updates, including removing that limitation and revising prostate cancer and benign prostatic hyperplasia safety information [2]. The Depo-Testosterone label effective 2026-08-21 still carried the old limitation text [1].

What dose does the label give?

The Depo-Testosterone label gives 50 to 400 mg by deep gluteal intramuscular injection every 2 to 4 weeks for replacement in hypogonadal men [1]. It says the suggested dosage varies with the age, sex and diagnosis of the patient and is adjusted according to response and adverse reactions [1]. The label says to confirm hypogonadism before starting, with serum testosterone measured in the morning on at least two separate days, both below the normal range [1].

What records matter when care changes hands?

A man 65 or older is not moving from pediatric to adult care, so the handoff is mainly a records transfer. The label's approved indications are primary and hypogonadotropic hypogonadism, so the documented diagnosis and the two morning testosterone results from separate days are the core records [1]. Other useful items are the current product, concentration, dose and interval, the hematocrit and hemoglobin trend, blood pressure readings, prostate cancer risk information, and anticoagulant or diabetes medicine doses [1][5]. The Endocrine Society guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year of therapy [5].

Does testosterone cypionate raise cardiovascular risk in older men?

TRAVERSE enrolled 5,246 men aged 45 to 80 with hypogonadism and preexisting or high risk of cardiovascular disease [3]. It tested daily 1.62% testosterone gel, not testosterone cypionate injections. The primary MACE rate was 7.0% with testosterone versus 7.3% with placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority [3]. Mean follow-up was 33 months [3].

The Depo-Testosterone label still contains older language: long-term safety trials have not been conducted, studies have been inconclusive for MACE, and some but not all studies reported an increased risk [1]. The same label warns that testosterone can increase blood pressure, which can increase cardiovascular risk over time, and says testosterone products are not recommended in uncontrolled hypertension [1]. It also lists serious cardiac, hepatic or renal disease as a contraindication [1].

What hematocrit monitoring does the label support?

The Depo-Testosterone label says to check hemoglobin and hematocrit periodically during long-term use [1]. It lists polycythemia as an adverse reaction [1]. A 2022 network meta-analysis of 29 placebo-controlled randomized trials (3,393 men) found intramuscular testosterone enanthate/cypionate raised mean hematocrit by 4.0% (95% CI 2.9 to 5.1) compared with placebo [4]. A retrospective review of 178 hypogonadal men found erythrocytosis (hematocrit above 50%) in 66.7% of men on injectable testosterone, 12.8% on gels, and 35.1% on pellets; the injection group was younger and had higher baseline hematocrit, and the study was not randomized [7]. A separate review reported a 315% greater risk of erythrocytosis (hematocrit above 0.52) with testosterone replacement than in controls [8].

Does testosterone help bone in men over 65?

A placebo-controlled trial in 211 men 65 or older with low testosterone found that one year of testosterone gel increased spine trabecular volumetric bone mineral density by 7.5% versus 0.8% with placebo (P<0.001) [9]. It also increased estimated spine strength [9]. The trial used testosterone gel, not testosterone cypionate injections [9].

What about prostate cancer and other conditions?

The Depo-Testosterone label lists known or suspected prostate cancer as a contraindication [1]. It also says geriatric patients treated with androgens may be at increased risk of prostatic hypertrophy and prostatic carcinoma, although conclusive evidence is lacking [1]. The Endocrine Society guideline recommends against starting testosterone in men with breast or prostate cancer, elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, or a myocardial infarction or stroke within 6 months [5]. It also recommends against starting in men planning fertility in the near term [5].

What interactions matter at a care transfer?

The Depo-Testosterone label says androgens may increase sensitivity to oral anticoagulants; the anticoagulant dose may need reduction, and INR and prothrombin time should be monitored more often when starting or stopping testosterone [1]. It says androgens may lower blood glucose and insulin requirements in diabetic patients [1].