Testosterone gel (AndroGel(R)) study first to show long-term benefits ...( died 163 hypogonadal men (mean age = 51...),Health

died 163 hypogonadal men (mean age = 51) 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 (AndroGel) at 5, 7.5 or 10 g per day. Dosage could be adjusted by the investigator at each study center depending on the patient's clinical symptoms and serum testosterone levels. All patients had previously participated in a six-month study comparing the efficacy of AndroGel with a testosterone patch. The six-month study was then extended to allow for 42 months of treatment. Safety data was compiled for all the participants; data analyses for efficacy included 123 subjects. AndroGel is manufactured by Unimed Pharmaceuticals, Inc., a Solvay Pharmaceuticals, Inc. Company.

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 (average of about 3 kg or 6.6 pounds) 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. Bone mineral density (BMD) increased by 0.76, 1.47 and 1.60 percent at the hip and 0.99, 3.10 and 3.80 percent at the spine after 6, 18 and 30 months of treatment. 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 throughou
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Contact: David Feuerherd
df@issuesmangement.com
310-215-0234
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed)
4-May-2004

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