Harbor--UCLA REI Study Shows Testosterone Gel Improves Sexual Function, Mood, Muscle Strength and Body Composition in Testosterone-Deficient Men
Findings reveal that gel has significantly less skin irritation than the patch, provides more consistent levels of testosterone
A little dab will now do those men who have low testosterone levels. The Food and Drug Administration has approved Unimed Pharmaceuticals AndroGel, a clear, testosterone-containing gel rubbed into the skin, as an alternative to current testosterone therapy. The prescription product comes in ketchup-like packets of natural testosterone, which men rip open, rub in the palm of their hands and then onto the skin of their shoulders or abdomens, according to Dr. Ronald S. Swerdloff, lead investigator of the study that led to the approval. "The skin acts as reservoir for the testosterone, which then gets released into the blood in a controlled fashion," says Dr. Swerdloff, chief of the division of endocrinology at Harbor-UCLA Medical Center, in Torrance, Calif. Men apply the gel daily.
Data presented today show that the new testosterone replacement therapy, testosterone gel, (which is available commercially as AndroGel 1% CIII), improves sexual function, mood, muscle strength, bone mineral density and body composition in testosterone deficient men. Data also showed that this testosterone gel in the doses selected for the study gave consistent levels of testosterone in the blood that were higher than the usually recommended dose of a testosterone patch. This data, representing a study conducted by 16 research centers in the United States, was presented at the current ENDO 2000, the annual meeting of the Endocrine Society.
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The 227-man study, comparing a new testosterone gel (AndroGel 5g to 10 g/day) to the testosterone patch Androderm (5mg/day), was the largest ever performed on men with low testosterone. The three arms of the study produced blood testosterone levels in the low normal, mid-normal and high normal range with the testosterone patch, low dose and high dose testosterone gels respectively. The study found that skin irritation was reported in only 5.5 percent of men using AndroGel, compared with 66 percent of men using the patch. Data also indicated that the testosterone gel in the 10g/day group significantly increased bone mineral density in the hip and spine as compared with the lower dose of testosterone gel and the patch, which showed no increase in bone mineral density. Testdren-ADP - The most effective testosterone delivery system ever developed. Testosterone supplementation also increases GH! A group of researchers from Virginia Tech and the University of Virginia determined that testosterone supplementation also markedly elevates growth hormone secretion in older males. This means that those who were contemplating expensive GH treatments, may simply rely on more testosterone steroids to boost their circulating GH levels.
Before the gel became available, men with low testosterone levels would either take injections of the hormone or wear patches with the hormone.But Dr. Swerdloff said injections would create immediately high blood levels of the hormone and that patients did not enjoy injecting themselves. Patches, he says, also could be irritating and some men complained that certain brands fell off. Other men did not feel comfortable wearing them in parts of their body that either spouses or girlfriends could see or that could be detected in a gym or at the beach.
"The improvements in sexual function, mood, lean body mass, bone density and muscle strength support the potential physical and psychological benefits of a testosterone gel," said Ronald S. Swerdloff, M.D., chief and professor of medicine, division of endocrinology, at the Harbor-UCLA Research and Education Institute in Torrance, CA. "In addition, the decreased skin irritation seen in men using the testosterone gel demonstrates an advantage of the gel delivery method."
Men using this testosterone gel reached maximum improvement in sexual function and mood within the first 30 days of treatment. In addition, percent fat was decreased in men using testosterone gel (5g/day:-0. 90+ 0.32 Kg, and 10g/day: -1.05+ 0.22 Kg) but was not significantly decreased in the testosterone patch group. Mean muscle strength was increased in the leg press exercise by 11 to 13 Kg and moderate mean muscle increases were also shown in arm/chest muscle strength. Lean body mass was increased in men taking 10g/day of testosterone gel by (2.74+ 0.28 Kg, p=0.0002) compared to those taking 5g/day.
AndroGel is a clear, colorless topical gel that men apply once daily to the shoulders, upper arms and/or abdomen. Upon application, this testosterone gel dries within a few minutes. The skin absorbs the testosterone and serves as a reservoir for the hormone, which slowly enters the bloodstream. Normal testosterone levels are restored soon after application. The U.S. Food and Drug Administration approved AndroGel in February 2000 for replacement therapy in men for conditions associated with low testosterone.
Side-effects experienced by patients in this study were anticipated and manageable. They included increases in hematocrit and hemoglobin without significant changes in lipids. Increases in average prostate specific androgen (PSA) levels remained in the normal range and correlated with testosterone levels. Men using the testosterone gel were able to adjust their dose up or down to 7.5g/day on day 90 if serum testosterone concentrations were outside the normal male range. No dose adjustment occurred in men taking the patch.
Androgens are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. AndroGel is not indicated for use in women and has not been evaluated in women. Pregnant women should avoid skin contact with AndroGel application sites in men. Testosterone may cause fetal harm.
Studies have shown that during vigorous skin-to-skin contact some of the testosterone in the testosterone gel can be transferred to the untreated individual. Residual testosterone on the skin can be removed with soap and water. Testosterone also should be used to improve athletic performance.
The Harbor--UCLA Research and Education Institute are the nationl 11th largest independent research institute and a leader in innovative medical research. A nonprofit medical research and education institute, REI is affiliated with Harbor--UCLA Medical Center and the UCLA School of Medicine. REI manages more than 500 research studies addressing nearly all aspects of health and medicine. Primary funding sources for research at REI include the NIH, the Centers for Disease Control and Prevention, and other federal, state and county agencies, as well as corporate, volunteer and community organizations, and private donations.
Men who need testosterone replacement therapy include younger men whose low levels apparently do not allow them to have male sexual characteristics, such as muscle mass, poor beard growth and a healthy sexual drive. Some 4 percent of men who are in the 20s have low testosterone levels. Whether testosterone replacement therapy for older men is appropriate remains an open question, says Dr. Swerdloff. Approximately 25 percent of men who are 65 years old have low testosterone levels. Decreased levels in older men could lead to reduced muscle mass, osteoporosis and depression. "Early studies on short-term use of testosterone replacement have shown some benefits for older men," says Dr. Swerdloff. "More studies need to be done to follow men for a longer period of time to make sure any benefits are not outweighed by long-term consequences. "But Dr. Stanley Korenman, professor of medicine and reproductive endocrinology at the UCLA Medical Center, feels the benefits for older men are already known. Older patients just need to have their blood count, their prostate specific antigen and their lipids watched when they are taking androgens, he says. Testosterone may thicken the blood, increase PSA and decrease HDL, the good cholesterol", he says.
When issuing the approval, the FDA cautioned the drug be used carefully. Men must be careful not to spread the gel from their hands or bodies to women, especially pregnant women because testosterone can harm a developing fetus, the FDA said. Let the gel dry a few minutes before dressing and wait five to six hours before showering or swimming so it absorbs properly, the FDA said. Illinois-based Unimed said AndroGel, like other testosterone therapy, can restore men's hormone levels to a normal range. It will be available by midsummer. A price has not been set. Unimed's president and CEO Robert Dudley says that approximately 500,000 to 1 million men in the United States have low testosterone levels and would be candidates for the gel. With this easier means of delivery of testosterone, also may come the potential for abuse. But Dr. Swerdloff reminds that male sex drive does not increase as levels of testosterone rise. Misuse by body-builders and athletes, however, could be possible.