RELEASE DATE:  March 4, 2004

NOTICE:  NOT-AG-04-004

National Institute on Aging (NIA)
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 
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 
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
For cognitive and neurological outcomes: 
Andrew Monjan, Ph.D. 
Gateway Building, Suite 350
National Institute on Aging 
Bethesda MD 20892-9205
(301) 496-9350

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