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Testosterone therapy is sometimes combined with an aromatase inhibitor for men with secondary hypogonadism who wish to conceive children with their partners. Aromatase inhibitors like anastrozole prevent the conversion of testosterone into estradiol by aromatase. In addition to the prevention of testosterone conversion into DHT, 5α-reductase inhibitors also prevent the formation of neurosteroids like 3α-androstanediol from testosterone, and this may have neuropsychiatric consequences in some men. For instance, growth of body and facial hair and penile growth induced by testosterone may be inhibited by 5α-reductase inhibitors, and this could be considered undesirable in the context of, for instance, puberty induction.
Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Cases of secondary exposure to testosterone have been reported in children. In addition to discontinuation of the drug, diuretic therapy may be required. Due to lack of controlled evaluations in women and potential virilizing effects, TESTIM is not indicated for use in women see CONTRAINDICATIONS and Use In Specific Populations. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is loosely bound to albumin and other proteins. The average daily testosterone concentration produced by TESTIM 100 mg at Day 30 was 612 (± 286) ng/dL and by TESTIM 50 mg at Day 30 was 365 (± 187) ng/dL. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has 2 main etiologies. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Treatment of overdosage would consist of discontinuation of TESTIM, washing the application site with soap and water, and appropriate symptomatic and supportive care. There is a single report in the literature of acute overdosage after injection of testosterone enanthate. There were no reports of overdose in the TESTIM clinical trials.
This document does not contain all possible drug interactions. This medication may harm an unborn or breastfeeding baby. Women who are pregnant or breastfeeding must avoid contact with this medication. This medication can affect fertility in males.
Alcohol-based products, including TESTIM, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the TESTIM has dried. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism see ADVERSE REACTIONS. Edema, with or without congestive heart failure, may be a serious complication in patientswith preexisting cardiac, renal, or hepatic disease.

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