DHHS/PHS/FDA/Office of Contracts and Grants Management, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Bldg., Rm 3-32, Rockville, Maryland 20857

A -- HORMONE REPLACEMENT THERAPY (HRT) STUDY SOL 223-95-3009 DUE 072195 POC Contact, Hamilton Brown, Contract Specialist, (301) 443-0424, M. Deborah Smith-Castle, Contracting Officer, (301) 443-0424 17 The Food and Drug Administration, Center for Drug Evaluation and Research, Division of Metabolism and Endocrine Drug Product, has a need for research to investigate the extent to which HRT is being used by women with a previous diagnosis of endometrial cancer. The study requires use of research data based upon a group of women who received a diagnosis of endometrial cancer within the past ten years; were studied at the time of diagnosis in a population-based case-control study of endometrial cancer in the United States for which results have been published in the medical literature, and in which the risk of endometrial cancer among women who had used HRT was estimated according to whether the use was of (1) ERT only, (2) EPRT with progestogen forless than 10 days per month, (2) EPRT with progestogen for more than or equal to 10 days per month. The FDA plans to procure the research from Fred Hutchinson Cancer Research Center (FHCRC) Seattle, Washington. This organization has the necessary prerequisite research database to perform this study over a one year period of performance. See Numbered Note 22. (0158)

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