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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.

Company: TheraTech
Approval Status: Approved on September 29, 1995
Treatment Area: hypogonadism

General Information

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).

Clinical Results

In clinical trials, Androderm restored normal testosterone levels in 86 of 94 subjects who completed the trials.

Side Effects

The most common side effects reported were temporary mild-to-moderate redness or itching at patch sites.

Additional Information

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 levels.

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 distribution).