Pharmaceutical companies promote testosterone gel as an elixir for old men with low energy or low sex drive -- but researchers at the University of Minnesota will put those claims to the test.
The U announced Monday it is one of 12 sites for a $45 million federal trial of testosterone gel. The study of 800 men will be one of the largest to examine the gel and whether it can reverse the symptoms that often have been associated with a natural drop in testosterone.
Smaller studies have produced conflicting results on whether these gels improve sex drive and whether they preserve vitality, muscle mass and cognition in older men, said Dr. Howard Fink, a general internist at the university and the Minneapolis VA Medical Center who will be part of the research team.
"The science is really unclear right now," he said.
Despite the lack of research results, sales of testosterone gels have been brisk. Solvay Pharmaceuticals posted nearly $500 million in global sales of AndroGel last year for the treatment of low testosterone, which has been branded as "Low T" in the company's commercials.
"There are no wrong answers, just answers," the AndroGel Web site advises.
"Losing muscle mass? Low sex drive? Lack of energy?" the Web site for rival Testim asks. "You could have low testosterone. Testim may help. Ask your doctor."
Such confidence is not reflected in groups such as the U.S. National Institute on Aging and the American Medical Association, which looked
at available evidence regarding testosterone therapy this year and found it difficult to draw any conclusions over its anti-aging benefits.
The U.S. aging institute is funding the upcoming trial, which will be centered at the University of Pennsylvania. The University of Minnesota will enroll 70 men who are 65 and older. Some will receive testosterone gel, while others will receive a placebo gel that has the same smell, color and consistency.
Men will be enrolled in one or more arms of the trial to determine if testosterone therapy improves any of the five conditions: anemia, decreased physical function, low vitality, impaired cognition or reduced sexual function.
"This study is important because testosterone products have been marketed for many years as treatments for a variety of conditions," said Dr. Evan Hadley, director of NIA's Division of Geriatrics and Clinical Gerontology. "We hope this trial will establish whether testosterone therapy results in clear benefits for older men."
The study bears similarities to the federally funded trial that raised alarms a few years ago over the safety of giving women synthetic estrogen to treat the symptoms of menopause.
However, this trial might not be large enough or long enough to adequately determine safety risks, which could include risks of prostate cancer, cardiovascular problems or urinary complications.
The U.S. Institute of Medicine has recommended a larger safety study if this study upholds the clinical benefits of testosterone therapy for older men.
In a statement, a Solvay spokeswoman said AndroGel was rigorously studied for its safety and effectiveness before it was approved by the U.S. Food and Drug Administration in 2000.
Aside from the clinical benefits, testosterone gel has been a hot topic in the news this year:
--Solvay is engaged in a legal battle to prevent generic versions of its gel.
--The FDA issued a warning after some children accidentally came in contact with gel that had been applied to other people.
--The Milwaukee Journal Sentinel examined whether payments of more than $100,000 from Solvay to University of Wisconsin doctors influenced their clinical and research judgments.
Minnesota payment records show that Solvay paid $40,970 in grants, meal reimbursements and promotional fees to doctors in this state over the past three years. Auxilium, the manufacturer of Testim, paid $29,654 to Minnesota doctors for research and consulting in 2007.
Jeremy Olson can be reached at 651-228-5583.
FYI
For information about the University of Minnesota trial, call 612-625-4449. Men with family histories of prostate cancer or other medical conditions will be excluded. To see more of the Pioneer Press, or to subscribe to the newspaper, go to http://www.twincities.com. Copyright (c) 2009, Pioneer Press, St. Paul, Minn. Distributed by McClatchy-Tribune Information Services. For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
Copyright (C) 2009, Pioneer Press, St. Paul, Minn.