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Preparation and Use of Androgenic Compounds: Nandrolone 17beta-carbonates
Description of Technology:
Hypogonadism is defined as deficient or absent male gonadal function that results in insufficient testosterone secretion. Hypogonadism can be caused by surgery; radiation; genetic and developmental disorders; liver and kidney disease; infection; and certain auto-immune disorders. The most common genetic disorders are Klinefelter syndrome found in men and Turner syndrome in women.
Hypogonadism affects an estimated 4 to 5 million men in the United States, and although it may occur in men at any age, low testosterone levels are especially common in older males. More than 60% of men over age 65 have free testosterone levels below the normal values of men aged 30 to 35. Studies suggest that hypogonadism in adult men is often underdiagnosed and under treated. This may be because the symptoms are easily attributed to aging or other medical causes, or ignored by patients and physicians. In fact, only about 5% of hypogonadal men receive testosterone replacement. Some experts also believe that we need to reevaluate normal testosterone levels and lower the diagnostic cutoff for hypogonadism. By doing so, many patients who we now consider to be "low-normal" would probably be considered candidates for androgen replacement.
The inventors have discovered androgenic compounds, the lead compound being 17beta-carbonates of nandrolone derivatives. These compounds can be used to treat hypogonadism, as hormonal therapy and as a male contraceptive. The disclosed carbonates have potent activity when administered as an oral composition. In addition, long-lasting activity has also been observed with subcutaneous administration in laboratory animals. It is foreseen that these androgens can be utilized in hormonal replacement therapy for both men and women, which constitute a huge market both in the United States and abroad.
Inventors:
Richard P. Blye and Hyun K. Kim (NICHD)
Patent Status:
DHHS Reference No. E-181-2004/0 --
U.S. Provisional Application No. 60/650,376 filed 04 Feb 2005
PCT Application No. PCT/US2006/02436 filed 24 Jan 2006, which published as WO 2006/083618 on 10 Aug 2006
U.S. Patent Application No. 11/815,532 filed 03 Aug 2007
Licensing Status:
Available for non-exclusive or exclusive licensing.
Collaborative Research Opportunity:
The NICHD Contraception & Reproductive Health Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.
Portfolios:
Internal Medicine - Therapeutics, contraceptives
Rare Diseases
For additional information, please contact:
Tara L. Kirby, Ph.D.
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville MD 20852
Phone: 301/435-4426
Fax: 301/402-0220
Email: tarak@mail.nih.gov
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