The clinical use of androgen replacement therapy for the treatment of hypogonadal men, or men with low testosterone levels, has led to discovery of its benefits for men with a variety of age-related symptoms, such as reduced sexual function, fertility, muscle strength, and bone mineral density.
While identifying suitable candidates for hormonal therapy continues to be challenging, and though criteria for its administration must first be carefully established, new studies of the benefits of testosterone replacement in aging men are compelling. The testosterone gel Testim® (Auxilium Pharmaceuticals, Inc., Norristown, PA) demonstrated good short-term and long-term results in several studies, by restoring testosterone levels and reducing andropausal symptoms. Because of the ease of use and few side effects, testosterone gels appear to have the potential to fill an important market need in a sizable treatment population.
The physiology and diagnosis of hypogonadism is first discussed by Dr. Christina Carnegie. Dr. Carnegie reviews the diagnostic paradigm for hypogonadism in prepubertal, postpubertal, and aging males. Dr. Carnegie stresses the importance of obtaining early morning testosterone levels of postpubertal and aging males. Also, digital rectal examination and prostate-specific antigen tests should be performed.
An overview of testosterone replacement therapy in men with andropause is presented by Dr. Michael K. Brawer. This article presents many of the challenges associated with both diagnosis and treatment of low testosterone levels. Dr. Brawer reviews the testosterone products clinically used to treat andropause: oral agents, patches, and transdermal gels.
This is followed by 2 in-depth studies using Testim. Dr. Edward Loizides presents the results of the Testim START Study, which used a questionnaire to determine at what point the daily treatment of Testim 1% gel began to affect sexual mood and function. In this study, men with low testosterone levels (≤ 300 ng/dL), in otherwise good health, received 1 tube of Testim 1% gel per day and applied the gel (50 mg testosterone) for 30 days. The questionnaire was completed for 7 days prior to Testim treatment and daily for 30 days of Testim treatment. The study concluded that response to Testim therapy occurs within the first week for sexual desire and nighttime erections and within 2 weeks for sexual activity.
In a second report by Dr. John D. Dean and colleagues, 371 hypogonadal men were enrolled in 2 multicenter, long-term studies in 39 centers in the United States and 10 centers in Scandinavia and Europe. Seventy-six patients received Testim for less than 6 months, 38 for 6 to 9 months, and 257 for more than 9 months. Serum T levels were normalized after the first month of treatment and the beneficial effects using Testim on sexual function and mood were maintained over a 12-month period.
The clinical case reports by Drs. Kendell Dupree and colleagues, Dr. Michael K. Brawer, Dr. John P. Mulhall, and Drs. John Gore and Jacob Rajfer conclude the supplement. These cases illustrate the beneficial effects of supplemental testosterone therapy for treating symptoms of osteopenia, sexual function, andropause, and erectile dysfunction.
This timely supplement presents an overview of the role of androgen replacement therapy in clinical practice today and presents a case for the adoption of hormonal therapy in the setting of prostatic disease.