Years in the making, the National Institutes of Health is recruiting for the Testosterone Trial, or T Trial. It is a great sign that the mistakes made with hormone replacement therapy in women--may not be repeated in men.

"This is a very important study and it should be supported," said H. Ballentine Carter, MD, professor of urology at Johns Hopkins Medical Institution, who consulted on designing the trial. Dr. Carter has underscored the importance of clinical trials before making a medication like this more widely available.

Peter Snyder, MD, principal investigator at the T Trial Coordinating Center, and professor of endocrinology at the University of Pennsylvania, Philadelphia, explained the background and rationale for the trial. "As men get older, there is a very slow decrease in their testosterone levels. With it, men develop abnormalities in physical functioning, sexual function, and cognition. Some men become diabetic, and may become anemic."

"One important question is whether decreasing testosterone levels are part of normal aging--not pathologic, a normal consequence and even adaptive," said Dr. Snyder. Another possibility is that low testosterone levels result in frank hypogonadism, fatigue, and loss of physical function. The hypothesis that we are working with is whether men who are 65 years or older and have low serum testosterone concentrations will improve their physical function, sexual function, vitality, cognitive function, and low hemoglobin concentration, as well as decrease risk factors for cardiovascular disease and diabetes."

According to Dr. Snyder, men who are age 65 and older and have low blood testosterone, may be eligible for the trial if they also have one or more of the following: difficulty walking a quarter of a mile, less interest in sex, or less vitality than they used to have. However, there are important exclusion criteria as well.

If you are accepted into the trial, you will be randomly assigned to receive a testosterone gel (AndroGel®, Solvay Pharmaceuticals) or a placebo that will be applied daily. You will be followed for a year. Over the course of the year, men will be tested by questionnaires and blood tests to determine if their walking, interest in sex, energy, memory and blood count are getting better.

Testing Efficacy First

The T trial follows recommendations from an Institute of Medicine Panel calling for "first establishing clear benefit before assessing long-term risks" and to testing testosterone as a therapeutic intervention in men most likely to benefit."

In other words, if efficacy remains unproven, there will not be a large-scale trial like the Women's Health Initiative, which followed thousands of women for years and was extremely costly. That trial would be moot, according to Dr. Snyder, if testosterone does not prove efficacious.

Up Against Testosterone Proponents

The trial comes on the heels of intense promoting of testosterone as a miracle vitality drug for men--both as a preventative and treatment drug. Books and articles have targeted the men's consumer press. Testosterone replacement therapy has been taken up frequently at large medical meetings and Continuing Medical Education programs. Perhaps, a short, well-controlled trial with clear results will put the issue of efficacy to rest.

Recruitment Information

A total of 800 men at 12 sites around the United States will be enrolled in the trial. To see if there is a study center to contact in your area, check the T Trial site.

Thanks to Jacob Goldstein at the Wall Street Journal Health Blog for a heads up on Sciele Pharma's efforts to build buzz, AKA "awareness" of its new premature ejaculation drug, PSD502, which is not yet available for market.

Sciele's PSD502 is a spray that contains 7.5mg of lidocaine and 2.5mg of prilocaine, and it is used 5 minutes before intercourse. Sciele expects to file for FDA approval in the spring.

Goldstein met them when they visited with the WSJ Health Blog and reports that they are presenting at meetings globally, talking to journalists at newspapers and magazines, and have created a website for bloggers.

Sciele's press release states that approximately "one-third of men ages 18-59 suffer from premature ejaculation, making it more prevalent than erectile dysfunction." Wow.

Also discussed in Sciele's press release is an evidence-based definition of premature ejaculation established by the International Society for Sexual Medicine (ISSM). In 2008, the ISSM characterized the condition as "ejaculation which occurs prior to or within one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy."

Could this be the next blockbuster sexual dysfunction drug? I wonder.

People with urology problems, such as an enlarged prostate, interstitial cystitis, or urinary incontinence often don't feel comfortable hitting the road for holiday travel. Panic sets in about where that next bathroom will be.

Here's a link that the National Association for Continence has on its website that shows you where you can find a public bathroom and a more detailed guide from About's irritable bowel syndrome guide, covering not just US travel, but elsewhere. It just might give you the confidence to take the trip that you thought you might not be able to make.

Gearing up for the United Nations Climate Change Conference in Copenhagen Dec. 7-18 (COP15), public health experts are pointing to an increase in kidney stones with global warming. Kidney stones are common in hot climates, where people easily become dehydrated and urine output is lower. In the United States, the southeast is considered the "kidney-stone belt."

A widely-quoted study on the adverse effects on climate change and kidney stones Proceedings of the National Academy of Sciences will be presented at the meeting.

Harvard researchers highlighted the findings recently as part of a public health initiative on global warming endorsed by the American Medical Association.

Based on predictions from the study, the authors project that if global warming continues to escalate, high-risk geographic areas for kidney stones will expand markedly, affecting more than 50% of the US population by 2050. Additionally, the study estimates an increase in kidney stone treatment to rise by between $900 million and $1.3 billion US dollars per year, equivalent to about 25% per year.

Related Reading

_{All about kidney stones.}

_{Brikowski T, Lotan Y, Pearle M. A painful truth: climate change will increase kidney stone disease. Denver, CO: Geol Soc America, 2007.}

_{Kidney stones. Prevention.}