Home » Drug Information » FDA Approved Drugs » 1995
Medical Areas: Cardiology/Vascular Diseases | Endocrinology
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Androderm (Testosterone Transdermal System)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved on September 29, 1995
Treatment Area: hypogonadism
Androderm, a skin patch that can be placed on different parts of
the body, boosts testosterone levels. It has been approved by the
FDA as a treatment for hypogonadism, a condition in which the body
produces inadequate levels of testosterone. Androderm helps to
relieve symptoms of both primary hypogonadism (disorders of the
testes) and secondary hypogonadism (disorders of the pituitary
gland or hypothalmus area of the brain).
In clinical trials, Androderm restored normal testosterone
levels in 86 of 94 subjects who completed the trials.
The most common side effects reported were temporary
mild-to-moderate redness or itching at patch sites.
A previously approved patch, Androderm can be placed on
different parts of the body. Transdermal patches offer alternatives
to testosterone injections, a therapy administered every two to
four weeks that can create abnormal highs and lows in hormone
Only about 5% of the estimated 4 million to 5 million American
men with hypogonadism currently receive testosterone replacement
therapy. Symptoms of the disorder include sexual dysfunction (loss
of libido or impotence), fatigue, depressed mood, muscle wasting,
osteoporosis, or absence or regression of secondary male sexual
characteristics (muscle development, deep voice, or hair