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Androgens and anabolic steroids are used as replacement therapy to treat delayed puberty in adolescent boys, hypogonadism and impotence in men, and to treat breast cancer in womenin some countries.
The majority of these treatments are given to adolescent boys, usually in combination with hormone replacement therapy. There is also a variety of medications that are given off label and may not always be administered by a doctor. Some of these meds, such as testosterone replacement therapy, are still regarded as investigational drugs, though they may be given off label. Others, e.g., the contraceptive patch, may be dispensed as prescription drugs by prescribers.
In this review, more than 50 studies comparing hormones with placebo, the active treatment received prior to puberty were reviewed (see Fig 1). There were no effects of estrogen use on growth, physical and psychological development, or sexual function during adolescence.
Hormone therapy was associated with significantly improved physical and psychological function in male adolescents. Improvements in physical performance occurred in only 30% of the patients receiving estrogen compared with 91% who received placebo at baseline, whereas improvements in emotional function were similar between the two groups. No significant effect was found on sexual function compared with placebo.
The most commonly cited safety report concerning the safety of hormone therapy is the Report of the Committee on Proposal and Acceptance of the Dietary Supplement Health and Education Act, (DSHEA) of 1994.1 In this report, the Food and Drug Administration (FDA) noted that the study design was very different from other FDA-approved studies of hormones for adolescent boys. The authors summarized two studies, using different protocols (see Fig 1) and different dosages of hormones. Both reported a reduction in the incidence of adverse events. However, in these two studies, there was no effect on sexual function.
A more recent study on the safety of hormone therapy was done with a large sample population of boys (more than 3,000 male adolescents). This was a prospective follow-up study using a randomized, double-blind design, and the overall safety of these treatments was similar to that of treatment with estrogen and placebo. These results supported the safety of estrogen as an addition to treatment for male adolescents with ADHD. It has been suggested that, due to the relatively high incidence of ADHD in this population, estrogen may be less risky than other hormones in this group of ADHD-affected boys. However, this study was limited to a single study population and could not address the safety of estrogen in boys as a combination with other therapies for the treatment of boys with ADHD [see Warnings and Precautions (5.1)].
In children in the treatment range, there
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