Study Says Testosterone Gel Effective For Treating Hypogonadism

24 May 2004
Study Says Testosterone Gel Effective For Treating Hypogonadism

Long-term use of a testosterone gel called AndroGel� is safe and effective for men with hypogonadism (low testosterone) according to a new study appearing in the Journal of Clinical Endocrinology & Metabolism. The study was conducted at multiple research centers in the U.S. under the direction of investigators at the Harbor-UCLA Medical Center.

With continuous AndroGel� treatment, men in the study experienced rapid and sustained improvements in sexual function and mood. Decreases in fat mass and increases in lean body mass were persistent with treatment. Additionally, gradual and progressive increases in bone mineral density were seen in the spine and hip.

"This AndroGel� study is the first to show long-term benefits and safety with testosterone gel - that's great news for men suffering from low testosterone," said Ronald Swerdloff of the Harbor-UCLA General Clinical Research Center. "This study shows 3 years of continued benefits and provides new information on the degree of safety for men treated with testosterone. Nevertheless, doctors must monitor their patients throughout therapy."

It is estimated that low testosterone affects about one in 10 men between the ages of 40 and 60 and more than two in 10 men over the age of 60. Studies show that men lose testosterone at a rate of approximately 10 percent each decade after age 30. Symptoms of low testosterone include diminished interest in sex, erectile dysfunction, reduced lean body mass, decreased bone mineral density, depressed mood and fatigue.

Researchers studied 163 hypogonadal men who received continuous replacement with testosterone gel for up to 42 months: 70 percent of the patients received testosterone gel for at least 30 months. Patients were treated with one percent testosterone gel at 5, 7.5 or 10 g per day. Dosage was adjusted by the investigators at each study center depending on the patient's symptoms and testosterone levels. The study results showed significant improvements in mood and sexual performance, motivation and activity soon after initiating testosterone replacement. These improvements were maintained throughout treatment. Lean body mass increased as early as three months after beginning treatment and was sustained with continuous treatment. Additionally, an increase in muscle strength associated with the increase in lean mass was reported. Hematocrit and hemoglobin levels increased as anticipated with androgen replacement, but the increase reached the maximum level at six to 12 months with no further increases with continued testosterone gel treatment. Prostate disease was seen in six patients. Skin irritability was reported as minimal and caused discontinuation in only one patient. Investigators recommend monitoring serum PSA levels and conducting a digital rectal examination in patients prior to initiating therapy and periodically throughout treatment.