Category Archives: Testosterone

A previous study by the University of Colorado Cancer Center reported the common side effect of low testosterone in men treated with the recently approved lung cancer agent, crizotinib. A new study published this week in the journal Cancer confirms this finding in a multi-national sample, details the mechanism of reduced testosterone, and provides promising preliminary evidence that widely available hormone replacement therapies can alleviate this side effect in many patients. Aurora, Colorado (PRWEB) April 19, 2013 "This was a wonderful collaboration between multiple centers confirming a side effect that had not been noted when the drug was initially approved by the FDA," says Ross Camidge, MD, PhD, investigator at the CU Cancer Center, director of the thoracic oncology clinical program at University of Colorado Hospital, and the paper's senior author. Specifically, the study which included researchers in the United States, Hong Kong, Italy and the UK found that in 84 percent of men treated with crizotinib, testosterone levels were below the lower limit of normal. Importantly, this study also showed, for the first time, that approximately 80 percent of these men had symptoms associated with their low testosterone such as sexual dysfunction or depression. Testosterone levels seemed to fall … Continue reading →

By Toni Clarke (Reuters) - An advisory panel to the U.S. Food and Drug Administration was sharply divided on Thursday over whether a drug made by Endo Health Solutions Inc can safely be prescribed for men with low testosterone. A panel of outside medical experts split 9-9, with some members saying the drug, Aveed, offers a valuable alternative to existing products, especially since it is already sold under the brand name Nebido outside the United States. Dr. William Cooper, professor of pediatrics and preventive medicine at Vanderbilt University School of Medicine, said he did not find anything in the data "of a magnitude that would make me concerned about the overall safety of the drug." Others were troubled by the risk associated with the drug of allergic reactions, which are not always predictable. "I think there's a real absence of data to prove it's truly safe," said Dr. Lewis Nelson, director of the fellowship in medical toxicology at New York University School of Medicine. Testosterone is a hormone produced in the testicles that is responsible for maintaining muscle bulk, bone growth and sexual function. Symptoms of low testosterone can include loss of libido, depression, decreased muscle mass and fatigue. Treatments … Continue reading →

(Reuters) - Reviewers for the U.S. Food and Drug Administration said safety data on Endo Health Solutions Inc's twice-rejected testosterone injection Aveed was "concerning" and showed that the therapy was associated with severe and immediate post-injection adverse events. No deaths were reported from the post-injection reactions, but resuscitations and hospitalizations were required in some cases, the reviewers said in documents posted on the FDA's website on Tuesday. (http://link.reuters.com/dem47t) "There are no known approaches to predict or prevent the occurrence of an Aveed-related severe post-injection reaction for any patient," the FDA reviewers said. "It is unclear whether a 'slowly administered' intramuscular injection or a 30 minute post-injection wait time in the healthcare provider's office will entirely mitigate this risk." Endo is seeking approval for Aveed as a replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone hormone. The FDA first denied approval to the therapy in 2008, citing safety concerns, and then again in 2009 as it continued to believe that the drug's risks outweighed its benefits. However, the reviewers said on Tuesday that the drug met the regulatory requirement for efficacy for a testosterone replacement indication. The reviewers said that while considering a risk … Continue reading →

By Genevra Pittman NEW YORK (Reuters Health) - Older men who use testosterone gel may see small improvements in their muscle-to-fat ratio but are unlikely to glean any benefits in flexibility, endurance and general ability to get around, new research suggests. Men participating in the study had low to normal testosterone levels, were at least 60 years old and were functioning at a relatively high level to begin with. It's still unclear how long-term use of testosterone might affect frailer and more disease-prone elderly men, researchers noted. "There may be specific populations of men for whom testosterone supplementation or replacement may be beneficial," said lead author Dr. Kerry Hildreth, from the University of Colorado School of Medicine in Aurora. "But it's really not clear that in otherwise healthy, functional men in that low-normal physiologic range that using testosterone either alone or in combination with exercise added much." The new findings, she said, suggest that testosterone "is widely used in people where it really may not be appropriate or may not provide the benefits that people think it's going to." Abbott donated the testosterone gel used in the study, Androgel. The gel is approved by the U.S. Food and Drug Administration … Continue reading →

LAS VEGAS, April 15, 2013 /PRNewswire/ -- Low T Center, America's leading authority on the treatment of low testosterone in men, is introducing its successful and proven testosterone therapy to Nevada with the opening of a new Low T Center today in Metro Las Vegas. (Logo: http://photos.prnewswire.com/prnh/20121211/DA27651LOGO) In addition to the Las Vegas opening, Low T Center is also opening a new Center in Colorado Springs today, their third in Colorado.There are now 25 Low T Centers operating nationally in eight states. Cities include: Las Vegas, Colorado Springs, Denver, Dallas/Fort Worth, Houston, San Antonio, Oklahoma City, Kansas City, Denver, Indianapolis, Nashville, Cincinnati and Columbus. The Dallas-Fort Worth based company operates all of its Centers; they are not a franchise. The new Las Vegas area Low T Center is located at 3041 W. Horizon Ridge Pkwy, Suite 165 A in Henderson, phone (702) 758-5698 and website http://www.LowTCenter.com.The Medical Director at the new center is Thomas Oyer, MD. Dr. Oyer has 40 years of medical experience in family practice, preventive medicine and wellness. His medical degree is from Ohio State University / College of Medicine. Mike Sisk, President of the Low T Center, says the Center is bringing new methods and philosophies … Continue reading →