FDA seeks large clinical trial of testosterone products

FDA seeks large clinical trial of testosterone products

It has been reported that US Food and Drug Administration (FDA) is asking companies, which manufacture testosterone products, for conducting a large clinical trial in order to find out t benefits and risks associated with use of the hormone.

Christine Nguyen, MD, of the FDA, and colleagues said in a New England Journal of Medicine perspective that their agency is calling testosterone drug makers for making efforts together on one large controlled trial.

Recently, researchers noted the difference between hormone therapy for males and females. They observed that the Women's Health Initiative gave answers of important questions regarding hormone replacement, together with its risks of breast cancer and heart attack. Experts said that there has not been a comparable trial for males.

According to Cynthia Stueknel, MD, of the University of California San Diego, practice of testosterone therapy is 20 years behind what has been found regarding women and the use of hormone therapy. As per Stueknel, "Until there are clinical trials that look at outcomes such as heart attack, stroke, and death, and other really big outcomes -- not just some of the more subtle surrogate outcomes -- we won't be able to answer those questions".

Nguyen and colleagues summed up the evidence base for the hormone products over the past few years. They observed in 2002 that it was reported by an Institute of Medicine report that no definitive evidence was there that increasing testosterone levels in older men was helpful or safe.


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