APPLICATIONS FOR INTERVENTION STUDIES ON EFFECTS OF ANDROGENS IN OLDER MEN RELEASE DATE: March 4, 2004 NOTICE: NOT-AG-04-004 National Institute on Aging (NIA) (http://www.nia.nih.gov/) The National Institute on Aging (NIA) is developing plans for clinical trials of testosterone therapy in older men, related to recommendations of a recent report by the Institute of Medicine, “Testosterone and Aging: Clinical Research Directions.” This report recommended that such testosterone trials be coordinated through a cooperative agreement or similar mechanism to produce a common core data set that would maximize the information obtained from different studies. A summary of the report and information on how to obtain the full report are available at: http://www.iom.edu/file.asp?id=16440 NIA anticipates issuing a solicitation for testosterone clinical trials later in 2004, with anticipated funding in 2005. In order to use resources most effectively, NIA may decline to accept certain other, investigator-initiated, applications for androgen intervention studies. (This applies to initial and revised applications for new grants, competing renewals, and competing supplements.) Decisions regarding acceptance will be made on a case-by-case basis. Researchers who are considering submission of investigator-initiated grant applications for androgen intervention studies in older men are strongly encouraged to contact NIA staff before preparing an application. Certain applications for androgen intervention studies in older men may be assigned to NIH Institutes or Centers other than NIA. Persons who may wish to submit applications on this topic and who desire their primary assignment to be to another NIH Institute or Center may wish to contact staff of these organizations. NIA Staff Contacts For all topics other than cognitive or neurological outcomes: Joanna Badinelli Gateway Building, Room 525A National Institute on Aging Bethesda MD 20892-9205 (301) 435-3046 E-mail: BadinelJ@nia.nih.gov For cognitive and neurological outcomes: Andrew Monjan, Ph.D. Gateway Building, Suite 350 National Institute on Aging Bethesda MD 20892-9205 (301) 496-9350 E-mail: monjana@nia.nih.gov
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