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Andropause - Male Menopause
Testosterone Gel's Benefits Sustained at 29 Months
By e internal medicine news:Timothy F. Kirn
Sep 24, 2002, 2:24pm

Improvements in libido and bone mass, and declines in fat mass were maintained throughout 29 months in hypogonadal men treated with testosterone gel.

Long-term use of 1% testosterone gel was not accompanied by any significant side effects, Dr. Ronald S. Swerdloff, professor of medicine at the University of California, Los Angeles, said.

The study, presented at the annual meeting of the Endocrine Society, was sponsored by Solvay Pharmaceuticals Inc., Marietta, Ga., maker of Androgel.

One of three doses of testosterone gel were given to 93 hypogonadal men, average age 52 years. Patients were started on 5 g/day and 10 g/day, with some subjects later adjusted to 7.5 g/day in order to achieve testosterone levels in the normal range. There were no control subjects. Before treatment, the men had serum total testosterone levels below 10 nmol/L and free testosterone levels of less than 0.2 nmol/L.

Bone mineral density increased throughout the follow-up period. Increases were greater at the spine than at the hip, as has been found in previous studies. Overall, bone mineral density increased an average of 4% in the spine and 2% in the hip.

Also, baseline bone mineral density at the spine was twice as high in the 10-g daily dosage as in the 5-g daily dosage, 0.4 g/cm2 versus 0.2 g/cm2, respectively. Sexual motivation and performance measures improved within the first 6 months of treatment. The percentage of patients reporting full erections improved from 60%-65% to 70%-75%, with no apparent difference between dosage groups. That improvement was maintained over the rest of the follow-up.

Lean body mass and total body mass changed similarly for all the dosage groups. For the group given the 10-g dosage, lean body mass rose by an average 3.5 kg at 30 months. Fat mass dropped by about 2.5 kg at 30 months.

Acne was reported by 2% of the patients using testosterone 5 g/day and by 12% of those using testosterone 10 g/day. Application site reactions occurred in 6% of those on the 5-g dosage and in 3% on the 10-g dosage. Mean serum prostate-specific antigen levels rose by 0.3 ng/mL for all patients, but there were no progressive increases after the initial increase.

Testosterone Replacement Risks Unknown

The benefits of testosterone replacement in hypogonadal men—increased bone mass, improved cognition, increased libido, increased erythropoiesis—have been well documented. The risks have not.

Dr. Peter J. Snyder, professor of medicine at the University of Pennsylvania, Philadelphia, noted the following concerns at the annual meeting of the Endocrine Society in San Francisco:

Prostatic hypertrophy. Testosterone replacement increases the size of the gland to normal, and presumably the risk of benign hyperplasia along with it. Dr. Synder participated in a multicenter study of 108 hypogonadal men given transdermal testosterone or placebo. “Prostate events” occurred in 16 of 54 testosterone patients and in 11 of 54 placebo patients.

Prostate cancer. No direct evidence has linked testosterone replacement with increased risk of prostate cancer. But prostate cancers that were not detectable by prostate-specific antigen (PSA) level or digital rectal exam were found by biopsy in 14% with low testosterone levels (JAMA 276[23]:1904-06, 1996).

Cholesterol. In Dr. Snyder's 3-year study, testosterone replacement did not change high-density lipoprotein cholesterol or triglyceride levels. Low-density lipoprotein levels dropped 16 mg/dL in patients given gel or placebo.