Notice Number: NOT-AG-05-001
Release Date: November 3, 2004
Response Due Date: January 28, 2005
The National Institute on Aging (NIA) has recently issued a Request for Applications (RFA) for planning and protocol development for a coordinated set of clinical trials on the efficacy and safety of testosterone treatment in older men for specific symptomatic conditions that may be related to low testosterone levels. The RFA is available in the NIH Guide for Grants and Contracts at http://grants1.nih.gov/grants/guide/rfa-files/RFA-AG-05-005.html. The planning project will begin in 2005; the trials are expected to begin in 2006. The symptomatic conditions for which efficacy of testosterone treatment may be tested are in four domains: weakness/frailty/disability, sexual dysfunction, cognitive dysfunction, and impaired vitality/well-being/quality of life.
Before and during the planning phase for these trials, the NIA is interested in obtaining additional information regarding the availability of data on the prevalence in older men of conditions in these domains, and of specific combinations of conditions in two or more domains (e.g., coexisting sexual dysfunction and cognitive dysfunction). Information on the relationship of these prevalences to differing levels of testosterone (e.g., in men with circulating testosterone levels greater than, vs. less than, 320 ng/dl) would be particularly useful. These data would be valuable in considerations regarding sample sizes and other design issues for the planned trials.
Specifically, the NIA seeks your help in identifying unpublished data, and/or stored blood or other biospecimens, from epidemiologic or other studies that could be analyzed to obtain this information.
Respondents are asked to provide the following information regarding such data or specimens. However, the information presented need not be limited to these areas.
1. Information on the study in which the data and/or specimens were obtained, including type of study, sample size, characteristics of the study population, duration of the observation period, and the current status of data and/or specimens e.g., final and/or raw data, blood/plasma samples repository, etc.).
2. Information on the specific phenotypes and measurements used to evaluate conditions in these four domains, the schedule of these measurements over the course of study, and the data available or derivable on prevalences of these conditions and on combinations of them, and their relationship to differing testosterone levels
3. Information on testosterone measurements used (if any), including measurement method, timing and frequency of testing. If testosterone levels were not measured but blood or other specimens is available, indicate the total number, type (e.g., blood, serum, etc.) and volume of specimens available for analysis, and time and frequency of sample collection in relation to other measurements.
4. Information on what additional data analyses or assays would be necessary to obtain the information requested, and the estimated date when the results could be available.
5. Any additional information, comments or suggestions that you think would be useful.Response and Process
This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIA. The purpose of this RFI is to identify potential data that may inform the design of future testosterone trials. The NIA does not intend to award a contract on the basis of responses to this RFI nor otherwise pay for the preparation of any information submitted or NIA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the NIA's evaluation of the information received. No basis for claims against the NIA shall arise as a result of a response to this RFI or the NIA's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.
Response in any of the areas listed above is welcome; respondents should not feel compelled to address all items. Please respond no later than January 28, 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.
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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