San Francisco Area: Testosterone Replacement Study, Injection vs. Patch

Several dozen clinics and physicians' practices in the San Francisco area are now enrolling volunteers in a study of testosterone replacement for men who have abnormally low testosterone levels. This study will compare testosterone injections every two weeks with replacement by a patch which is worn daily on the scrotum; some volunteers will receive a placebo for the first 12 of the 24 weeks of the trial. (Both treatment options are already approved, and can be prescribed by any physician.) All study-required treatments and tests in the study will be free, except for an initial test for either free or total testosterone level.

Low testosterone in men can cause fatigue, loss of energy, reduced sense of well being, reduced sexual drive, and possibly loss of muscle and lean body mass; this deficiency (whether or not HIV-related) has long been treated by testosterone injections. The patch may be a better replacement option, however, as the testosterone is delivered daily, like natural testosterone, not every two weeks as with the injections. Testosterone replacement should not be used in men with known or suspected prostate or breast cancer.

The new study, called Testosterone Replacement in HIV-Related Hypogonadism, is being run by the Community Consortium, an organization of physicians in San Francisco Bay Area. It will randomly assign people to receive either the injections (intra-muscular testosterone enanthate, 200 mg every two weeks) or the patch (Testoderm(TM) by ALZA, worn on the scrotum, which must be shaved). In each of these two groups, two thirds of the volunteers will receive active drug throughout the 24 weeks of the study; the other 1/3 will receive a placebo for 12 weeks, then switch to active drug.

Everyone will have lean body mass measured by DEXA scans (dual energy x-ray absorptiometry), and by BIA (bioelectrical impedance analysis), performed at the General Clinical Research Center (GCRC) of San Francisco General Hospital. Other measurements include weight, serum testosterone levels, CD4 and CD8 counts, viral load, changes in quality of life questionnaires, and self-reported compliance with the study regimens.

This study is open to men over 17 years old, with either serum or free testosterone level below normal. For men over 40, the PSA (prostate-specific antigen, an indication of possible prostate cancer) must be no greater than 4.0. To avoid biasing the study, volunteers cannot have been hospitalized within the last month; and they must not have had a severe illness resulting in loss of more than 10 percent of body weight within six weeks, nor changed their antiretroviral treatment within 30 days.

In order to enter this study, you must be seen for your routine care by a physician at a participating site. You can find out if your clinic or physician is participating by calling the Community Consortium, 415/502-0658.

Note: A separate multi-center trial of the Testoderm patch is now being planned.

Comment

Anyone considering testosterone replacement should know that there is now a new testosterone patch which does not need to be worn on the scrotum, but can be worn on the abdomen, back, thighs, or upper arms. This is the Androderm(TM) Testosterone Transdermal System, which was approved by the FDA on October 2, 1995. It is marketed by SmithKline Beecham, and should be in the pharmacies soon. Its main disadvantage is that it often causes skin irritation at the application site.

Another testosterone replacement system is a jell which has been approved in France for ten years; it is not currently available in the U.S., but will soon by tested here by UNIMED, Inc. The jell is applied to the forearm, and delivers a daily dose of testosterone in about 45 seconds.