Testim® should not be used in patients with known hypersensitivity to any of its ingredients, including testosterone USP that is chemically synthesized from soy. Serious side effects include worsened symptoms of an enlarged prostate. Testim 1% (testosterone gel) is a prescription medicine that contains testosterone. Other side effects include more erections than are normal for you or erections that last a long time. You are encouraged to report negative side effects of prescription drugs to the FDA. The study was double-blind for the doses of TESTIM and placebo, but open-label for the non-scrotal testosterone transdermal system. When males wore a long-sleeved T-shirt and rubbing was started at 1 and at 4 hours after application, the transfer of testosterone from male to female partners was prevented.
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.
Common side effects of testosterone include acne, swelling, and breast enlargement in men. If this occurs, the child may have unwanted side effects due to testosterone gel. Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. The number of days with spontaneous erections increased by 137% at Day 30 and was maintained at 78% at Day 90 for Testim®-treated patients compared to baseline.
At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH). During exogenous administration of androgens, endogenous testosterone release may be inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Androgens have been reported to stimulate the production of red blood cells by enhancing erythropoietin production. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Testosterone and dihydrotestosterone (DHT), endogenous androgens, are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Safety and efficacy of Testim® in patients less than 18 years old has not been established.
Table 1 summarizes the mean testosterone concentrations on Day 30 for patients receiving Testim® 50 mg or 100 mg. After 90 days of treatment, mean DHT concentrations remained generally within the normal range for Testim®-treated subjects. Figure 1 summarizes the 24-hour pharmacokinetic profile of testosterone for patients maintained on Testim® 50 mg or Testim® 100 mg for 30 days. The pharmacokinetics of Testim® have been evaluated with administration of doses containing 50 mg and 100 mg of testosterone to adult males with morning testosterone levels ≤300 ng/dL. There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses.
However, when given to men with hypogonadism in the short- and medium-term, testosterone replacement therapy does not increase the risk of cardiovascular events (including strokes and heart attacks and other heart diseases). The FDA now requires warnings in the drug labeling of all approved testosterone products regarding deep vein thrombosis and pulmonary embolism. Due to an increased incidence of adverse cardiovascular events compared to a placebo group, a Testosterone in Older Men with Mobility Limitations (TOM) trial (a National Institute of Aging randomized trial) was halted early by the Data Safety and Monitoring Committee. Results from the TRAVERSE trial were submitted in 2023, concluding that there was no increase in the risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism. The FDA stated in 2015 that neither the benefits nor the safety of testosterone have been established for low testosterone levels due to aging. In women, testosterone can produce hirsutism (excessive facial/body hair growth), deepening of the voice, and other signs of virilization.
Alternatively, testosterone products for women are available from compounding pharmacies in the United States, although such products are unregulated and manufacturing quality is not ensured. There are no testosterone products approved for use in women in the United States and many other countries. Other androgenic side effects, such as weight gain, pattern hair loss, and voice deepening, were also reported in some trials, but were excluded from analyses due to insufficient data. Women who were menopausal due to ovariectomy showed significantly greater improvement in sexual function with testosterone relative to those who had normal menopause. These domains included frequency of sexual activity, orgasm, arousal, and sexual satisfaction, among others.