Women's Health Across the Nation - Endocrine Lab

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DESCRIPTION (provided by applicant): This one year competing renewal is submitted as one of a set of nine component applications (including seven clinic sites, the Coordinating Center and a Central Endocrinology Laboratory) to augment the last year of the current five-year renewal (SWAN II) of the nine originally funded applications in response to RFA AG-94-002, "Menopause and Health in Aging Women." The purpose of this renewal is to complete a sixth annual follow-up visit on approximately 2470 women across clinical sites and a final annual cycle of daily urine collections on approximately 550 women. Each of these data collection activities requires a two-year period for completion. The SWAN II application included funding to finish Visit 02 to the Visit 00 and Visit 01 data collections, to undertake Visits 03, 04 and 05 data collections and to spend the final year on analyses. Preliminary data now available from Visits 00-03 indicate that the original and continuing aims of this important study cannot be addressed with the currently funded five years of follow-up observation as the number of menopause transitions will be insufficient. Projections indicate that nine years of follow up will be required. Bridging funding (this supplement application) is needed so that a one year gap in cohort follow-up to complete a Visit 06 can be closed. A competing renewal for five years (SWAN III) must be predicated on continuing data collection so that cohort retention, follow-up integrity and certified staff availability is assured. Hence there is a need to obtain this supplemental funding to bridge the time in the SWAN II that was planned for closeout and data analysis. To assess endocrine changes in midlife women, the University of Michigan?s Central Ligand Assay Satellite Services (CLASS) laboratory will continue to support SWAN by using state-of-the-science, automated assays for all the major reproductive axis hormones (LH, FSH, E2, P, and T), adrenal markers of aging (DHEAS), other endocrine markers (TSH, SHBG) and new ovarian markers which have the potential to allow us to hormonally define the menopausal transition and the postmenopause with greater precision (inhibin B, estrone). In order to continue to support the Daily Hormone Study, CLASS will utilize sensitive and specific urinary assays for LH, FSH and the principal urinary metabolites of estradiol and progesterone, estrone conjugates and pregnanediol glucuronide, respectively. To assess endocrine changes in midlife women, the University of Michigan?s Central Ligand Assay Satellite Services (CLASS) laboratory will continue to support SWAN by using state-of-the-science, automated assays for all the major reproductive axis hormones (LH, FSH, E2, P, and T), adrenal markers of aging (DHEAS), other endocrine markers (TSH, SHBG) and new ovarian markers which have the potential to allow us to hormonally define the menopausal transition and the postmenopause with greater precision (inhibin B, estrone). In order to continue to support the Daily Hormone Study, CLASS will utilize sensitive and specific urinary assays for LH, FSH and the principal urinary metabolites of estradiol and progesterone, estrone conjugates and pregnanediol glucuronide, respectively.