Notice Number: NOT-AG-05-005
Release Date: August 11, 2005
Response Due Date: October 11, 2005
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
The NIA is interested in obtaining information from the academic and industrial community as to the availability of different testosterone formulations and matching placebo preparations. These would be used in a double blinded, placebo controlled testosterone efficacy study on up to 2000 volunteer subjects for up to 12 months of treatment. The entire study would take up to 6 years to complete.
The NIA seeks your help in identifying (a) potential FDA approved or pending FDA approval testosterone formulations, their recommended dosages, routes of administration, efficacy and safety profiles; b) the critical steps or barriers to the use of these formulations in the expected clinical trials; and c) the interest of members of the academic and/or industrial community to provide testosterone product and matching placebo either for a fee or gratis to the NIA or its awardee for the conduct of such large scope, high visibility efficacy trials. Your thoughts, ideas, and suggestions will help the NIA evaluate potential benefits and risks of the available testosterone formulations and select a product that will be used in the planned testosterone trials in older men. Respondents are asked to comment on the issues below.
1. Identify and describe potential testosterone products, their pharmacokinetics, recommended dosages, routes of administration, efficacy and safety profiles.
2. Provide the licensure status of any products identified in response to item 1.
3. For unlicensed products, provide the current development status such as filing of an IND, and the initiation or completion of Phase I, II, and III clinical trials.
4. For any potential products, provide the availability of the product and matching placebo, including the timeframe for scale-up and production.
5. Comment on your interest in collaborating with NIA or its awardee on conducting a safety and efficacy clinical trial with the designated product and your willingness to donate the product to the NIA or its awardee for use in such a 12 month intervention trial which would take up to 6 years to enroll, treat (up to 2000 men) and evaluate the data.
6. Provide any additional comments or suggestions that you think would be useful.
Response and Process
Response in any of the areas is welcome; respondents should not feel compelled to address all items. Please respond no later than October 11, 2005. We look forward to your thoughts, opinions, and suggestions, and hope you will share this document with your colleagues. All responses will be kept confidential. Thank you very much for your help.
To respond, please send a letter, fax, or email to the following address:
Sergei V. Romashkan, MD, PhD
Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
Gateway Building, Suite 525A
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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