NERI To Launch First Multi-National Observational Registry For Men Diagnosed With Testosterone Deficiency

Main Category: Men's health
Article Date: 13 Feb 2009 - 2:00 PDT

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New England Research Institutes, Inc. (NERI), is developing and launching a large, multi-national observational (non-intervention) registry for men with testosterone deficiency, a condition also known as hypogonadism (HG) or androgen deficiency. The Registry of Hypogonadism in Men (RHYME) will examine the natural history, progression, and current treatment options for the disease. In particular, it will examine the association between testosterone deficiency, testosterone therapy and prostate health. With primary funding from Bayer Schering Pharma AG, approximately 1,000 men at 20 clinical research sites in Europe, and possibly an additional 200 men at 10 sites in North America, will participate in the registry for a minimum of two years.

HG is characterized by reduced circulating testosterone levels and symptoms suggestive of low testosterone. It is one of the most common endocrine disorders in men, affecting approximately one in four men above the age of 60. HG can be acquired or congenital and RHYME will enroll men from either category.

According to data from the Boston Area Community Health (BACH) Survey, it is estimated that by 2025 up to 6.5 million U.S. men between the ages of 30-79 years could have symptomatic HG. Despite increasing evidence of the benefits of testosterone therapy for many men with testosterone deficiency, important knowledge gaps remain about the long term effects of testosterone therapy on prostate health and safety in older men with hypogonadism. Information is also lacking on the practice patterns of physicians in this area, and which patients are more or less likely to receive evaluation and treatment for their condition. To date, screening and diagnostic approaches for testosterone deficiency have not been evaluated in large, clinically representative groups of men.

"At NERI, we are all aware of the vital need and importance of conducting this first-ever registry," said Raymond C. Rosen, Chief Scientist, NERI. "It will provide 'real world' outcomes data that is consistent with the current standard of care for men with low testosterone and will help physicians to better evaluate and treat these men," continued Rosen. "The RHYME registry will be a valuable scientific resource for designing future clinical studies and a unique source of clinical data about male HG and its treatment."

Current research has shown that testosterone is essential for normal bone mass, muscle mass and strength, cognitive functions, mood and sense of well-being, and adequate maintenance of sexual function, including sexual desire and interest. It also has implications for vascular, cardiovascular and immune system health, and plays an important role in blood sugar control.

About NERI

NERI is a global, privately held specialty CRO that provides customized clinical trial solutions and patient registry services to pharmaceutical, biotechnology, biomaterial and medical device companies. NERI also has notable experience collaborating on federally-funded research with organizations like the National Institutes of Health (NIH). Since its founding in 1986, NERI has earned widespread recognition for its scientific credibility, efficiency and expertise in conducting clinical trials in a variety of medical specialties. NERI has an impressive track record working on Phase II, III and IV multi-site clinical trials.

NERI

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