The effect of chronic treatment with testosterone enanthate (TE) on sperm production and plasma testosterone levels was evaluated in 16 healthy male volunteers. During the induction of azoospermia each subject received 200 mg TE twice a week for 2 weeks once a week for 2 weeks, and once every other week for a month. Subsequently an attempt was made to maintain azoospermia by administration of 200 mg TE every 3 weeks. The induction phase resulted in suppression of sperm production to azoospermia or oligospermia of less than 100,000/ml. However, the schedule of injections during the maintenance phase did not maintain the azoospermic state. Consequently, the frequency of injections for maintenance was increased to 200 mg TE every 2 weeks. This maintained sperm counts below 3 million/ml in all subjects. Thereafter the maintenance schedule was changed to 200 mg TE every 10–12 days; on this regimen, azoospermia or oligospermia of less than 100,000/ml was maintained in all subjects. Blood testosterone levels rose approximately 100% over the baseline level during the induction phase but returned to pretreatment range during maintenance phase.
This study demonstrates that testosterone enanthate can induce azoospermia and maintain the azoospermic state without elevation of circulating testosterone levels outside the pretreatment range. These findings suggest the feasibility of using a testosterone preparation as an effective male contraceptive. A larger number of subjects must be evaluated to determine the exact dose requirements and the possibility of side effects subsequent to chronic administration of this steroid.
May cause hypercalcemia in patients w/ breast cancer or immobilized patients; d/c if this occurs. Peliosis hepatis and hepatic neoplasms, (eg, hepatocellular carcinoma) reported w/ prolonged use of high doses. D/C if cholestatic hepatitis, jaundice, or abnormal LFTs occur. May increase risk of prostatic hypertrophy and prostatic carcinoma in elderly. Venous thromboembolic events reported; evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for deep vein thrombosis and those who present w/ acute SOB for pulmonary embolism. D/C treatment and initiate appropriate workup and management if venous thromboembolic event is suspected. Increased risk of major adverse cardiovascular events (MACE) reported. Edema w/ or w/o CHF may be a serious complication in patients w/ preexisting cardiac, renal, or hepatic disease; may require diuretic therapy in addition to discontinuation of therapy. Gynecomastia may develop and persist. Caution in healthy males w/ delayed puberty; monitor bone maturation by assessing bone age of wrist and hand every 6 months. May accelerate bone maturation w/o producing compensatory gain in linear growth in children; compromised adult stature may result. Monitor for signs of virilization in females; d/c therapy at evidence of mild virilism. May alter serum cholesterol concentration; caution w/ history of MI or coronary artery disease. Not indicated in geriatric patients who have age-related hypogonadism only (“andropause”). Rare reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after administration. Caution in women w/ metastatic breast carcinoma as androgen therapy occasionally appears to accelerate the disease.