Approved & therapeutic
Testosterone cypionate
Depo-Testosterone
An injectable ester of testosterone approved in the United States as replacement therapy in males with primary hypogonadism or hypogonadotropic hypogonadism. It is a Schedule III controlled substance.
- Status
- Testosterone cypionate is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Approximately 8 days after intramuscular injection, per the US label.
- How it's taken
- Intramuscular injection only, given deep into the gluteal muscle. Not for intravenous use. Not interchangeable with testosterone propionate because of the difference in duration of action.
- Mechanism
- Reproductive axis (GnRH / kisspeptin / oxytocin)
- Pathways
- Androgen
How Testosterone cypionate works
The cypionate ester is released slowly from an intramuscular depot and hydrolysed to testosterone, which binds androgen receptors in target tissues; part is aromatised to estradiol and part reduced to dihydrotestosterone. Because exogenous androgen suppresses pituitary LH and FSH release, endogenous testosterone production and spermatogenesis fall during treatment.
What research has looked at
- Labeled for replacement therapy in males with conditions associated with deficiency or absence of endogenous testosterone, specifically primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
- The cypionate ester is absorbed slowly from the intramuscular depot; the label's only pharmacokinetic statement is a half-life of approximately eight days after intramuscular injection. The label makes no efficacy claim beyond replacing deficient hormone.
- Outside the label, the Testosterone Trials in men aged 65 and over with low testosterone found improvement in sexual activity, desire and erectile function against placebo, but the Vitality Trial did not meet its primary endpoint (FACIT-Fatigue) and the Physical Function Trial did not meet its primary endpoint (6-minute walk distance); bone density and strength and correction of anemia were separate or secondary results. That evidence comes from the age-related low-testosterone population the label's Limitation of Use excludes, so it should not be read as support for use in that group.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Contraindicated in males with carcinoma of the breast, in males with known or suspected carcinoma of the prostate gland, in women who are pregnant, in patients with serious cardiac, hepatic or renal disease, and in known hypersensitivity to the drug.
- Cardiovascular outcomes are unresolved on the label: long-term clinical safety trials have not been conducted for this product, epidemiologic studies and randomized trials are described as inconclusive for major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death), and some studies, but not all, have reported an increased risk. Patients should be informed of this possible risk.
- Testosterone can increase blood pressure, which can increase cardiovascular risk over time; blood pressure requires periodic monitoring, especially in men with hypertension, and testosterone products are not recommended in uncontrolled hypertension.
- Polycythemia: haemoglobin and haematocrit require periodic checks during long-term androgen therapy. Postmarketing reports of venous thromboembolic events including deep vein thrombosis and pulmonary embolism.
- Suppression of spermatogenesis, oligospermia and testicular atrophy; gynecomastia that occasionally persists; priapism or excessive sexual stimulation.
- Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Geriatric patients treated with androgens may be at increased risk of prostatic hypertrophy and prostatic carcinoma, although the label notes conclusive evidence is lacking.
- Edema with or without congestive heart failure, which may be a serious complication in pre-existing cardiac, renal or hepatic disease; hypercalcemia in immobilised patients, requiring discontinuation.
- Hepatic effects: prolonged use of high doses of androgens, principally the 17-alpha-alkylated androgens, has been associated with peliosis hepatis, hepatic adenoma and hepatocellular carcinoma. Testosterone cypionate is not 17-alpha-alkylated.
- Metabolic and interaction effects: serum cholesterol may increase; androgens may increase sensitivity to oral anticoagulants so the anticoagulant dose may need reduction; in diabetes androgens may lower blood glucose and insulin requirements.
- Contains benzyl alcohol, which has been associated with gasping syndrome and death in pediatric patients and can cross the placenta. In children androgen treatment may accelerate bone maturation without compensatory linear growth and compromise final adult height. Not recommended in nursing mothers.
- Safety and efficacy in age-related hypogonadism have not been established and the label retains a Limitation of Use for that population. Not shown to be safe and effective for enhancement of athletic performance, and the label states it should not be used for that purpose because of the potential risk of serious adverse health effects.
- Abuse and dependence: a Schedule III controlled substance, typically abused at doses higher than recommended and in combination with other anabolic androgenic steroids, with serious cardiovascular and psychiatric adverse reactions and withdrawal symptoms reported in that setting.
Sources
- PubMed research on Testosterone cypionate · NIH · National Library of Medicine
- DrugBank record for Testosterone cypionate · DrugBank
- Active clinical trials for Testosterone cypionate · U.S. National Library of Medicine
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Testosterone cypionate FAQ
What is Testosterone cypionate?
An injectable ester of testosterone approved in the United States as replacement therapy in males with primary hypogonadism or hypogonadotropic hypogonadism. It is a Schedule III controlled substance.
How does Testosterone cypionate work?
The cypionate ester is released slowly from an intramuscular depot and hydrolysed to testosterone, which binds androgen receptors in target tissues; part is aromatised to estradiol and part reduced to dihydrotestosterone. Because exogenous androgen suppresses pituitary LH and FSH release, endogenous testosterone production and spermatogenesis fall during treatment.
Is Testosterone cypionate FDA approved?
Yes. Testosterone cypionate is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Testosterone cypionate?
Reported half-life: Approximately 8 days after intramuscular injection, per the US label.
How is Testosterone cypionate taken?
Intramuscular injection only, given deep into the gluteal muscle. Not for intravenous use. Not interchangeable with testosterone propionate because of the difference in duration of action.
What side effects have been reported with Testosterone cypionate?
Reported in the sources: Contraindicated in males with carcinoma of the breast, in males with known or suspected carcinoma of the prostate gland, in women who are pregnant, in patients with serious cardiac, hepatic or renal disease, and in known hypersensitivity to the drug; Cardiovascular outcomes are unresolved on the label: long-term clinical safety trials have not been conducted for this product, epidemiologic studies and randomized trials are described as inconclusive for major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death), and some studies, but not all, have reported an increased risk. Patients should be informed of this possible risk; Testosterone can increase blood pressure, which can increase cardiovascular risk over time; blood pressure requires periodic monitoring, especially in men with hypertension, and testosterone products are not recommended in uncontrolled hypertension; Polycythemia: haemoglobin and haematocrit require periodic checks during long-term androgen therapy. Postmarketing reports of venous thromboembolic events including deep vein thrombosis and pulmonary embolism; Suppression of spermatogenesis, oligospermia and testicular atrophy; gynecomastia that occasionally persists; priapism or excessive sexual stimulation; Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Geriatric patients treated with androgens may be at increased risk of prostatic hypertrophy and prostatic carcinoma, although the label notes conclusive evidence is lacking; Edema with or without congestive heart failure, which may be a serious complication in pre-existing cardiac, renal or hepatic disease; hypercalcemia in immobilised patients, requiring discontinuation; Hepatic effects: prolonged use of high doses of androgens, principally the 17-alpha-alkylated androgens, has been associated with peliosis hepatis, hepatic adenoma and hepatocellular carcinoma. Testosterone cypionate is not 17-alpha-alkylated; Metabolic and interaction effects: serum cholesterol may increase; androgens may increase sensitivity to oral anticoagulants so the anticoagulant dose may need reduction; in diabetes androgens may lower blood glucose and insulin requirements; Contains benzyl alcohol, which has been associated with gasping syndrome and death in pediatric patients and can cross the placenta. In children androgen treatment may accelerate bone maturation without compensatory linear growth and compromise final adult height. Not recommended in nursing mothers; Safety and efficacy in age-related hypogonadism have not been established and the label retains a Limitation of Use for that population. Not shown to be safe and effective for enhancement of athletic performance, and the label states it should not be used for that purpose because of the potential risk of serious adverse health effects; Abuse and dependence: a Schedule III controlled substance, typically abused at doses higher than recommended and in combination with other anabolic androgenic steroids, with serious cardiovascular and psychiatric adverse reactions and withdrawal symptoms reported in that setting.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.