Testosterone Cypionate Compassionate Use and Expanded Access: A Complete Guide

Is testosterone cypionate available through compassionate use?

Testosterone cypionate is already available as an FDA-approved injection for replacement therapy in men with primary or hypogonadotropic hypogonadism. Depo-Testosterone, the product covered by this label, is given by deep intramuscular injection [1]. Because it is approved, the route to treatment is an ordinary prescription for an approved indication.

If a clinic uses the phrase compassionate use for testosterone, the first question is which product is being proposed. The Azmiro label says injectable testosterone products may have different doses, strengths or administration instructions and are not substitutable milligram for milligram. The Depo-Testosterone label describes deep gluteal intramuscular injection [1].

Who qualifies for the approved injection?

The Depo-Testosterone label limits use to men with symptoms of testosterone deficiency or absence from primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (pituitary or hypothalamic cause) [1]. Before starting, the label says to confirm hypogonadism by measuring serum testosterone in the morning on at least two separate days and finding both values below the normal range [1].

The label also says safety and efficacy in men with age-related hypogonadism have not been established [1]. FDA says none of the approved testosterone products are approved for men with low testosterone who lack an associated medical condition [2]. In June 2026 FDA requested that manufacturers remove that limitation of use and revise prostate cancer and benign prostatic hyperplasia safety information [2]. The Depo-Testosterone label still carries the old limitation, so the accurate wording is that FDA has asked for the change, not that the label now says it [1][2].

What dose and form does the label describe?

The label says Depo-Testosterone is for intramuscular use only and should not be given intravenously. For replacement in the hypogonadal male it gives 50 to 400 mg every two to four weeks, injected deep in the gluteal muscle [1]. The half-life after intramuscular injection is about eight days [1].

What safety issues come with the prescription?

Depo-Testosterone has no boxed warning [1]. The label warns that testosterone can increase blood pressure, which can increase cardiovascular risk over time, and that testosterone products are not recommended for patients with uncontrolled hypertension [1]. It also still contains an older paragraph saying long-term cardiovascular outcome trials have not been conducted and that some studies, but not all, have reported an increased risk of major adverse cardiovascular events; it does not mention TRAVERSE [1].

The label reports venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, and says to discontinue testosterone cypionate and start appropriate workup if one is suspected [1]. Polycythemia is listed among the adverse reactions [1].