Viewing Study NCT00455741



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Study NCT ID: NCT00455741
Status: COMPLETED
Last Update Posted: 2018-05-18
First Post: 2007-04-02

Brief Title: Postmenopausal Women Estrogen and Progesterone Infusion
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Effect of Age on Gonadotropin Responses to Short-Term Negative and Positive Feedback Effects of Gonadal Steroids Using PET Scanning
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to study the effects of aging estrogen and progesterone on the brain Specifically we want to look at how the hypothalamus and pituitary two small glands in the brain respond to estrogen The pituitary gland is controlled by the hypothalamus The hypothalamus secretes GnRH Gonadotropin-Releasing Hormone that signals the pituitary to secrete the reproductive hormones LH Luteinizing Hormone and FSH Follicle Stimulating Hormone These hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone Estrogen in the bloodstream then acts on the brain to modulate this system with changes in LH and FSH Early changes associated with low levels of estrogen are inhibitory estrogen negative feedback while higher levels of estrogen such as those present when a follicle in the ovary is ready to ovulate stimulate LH to cause ovulation positive feedback This study will determine 1 hypothalamic and pituitary levels of glucose uptake as a measure of brain metabolic activity at baseline and in association with estrogen negative feedback on LH 24 hr and estrogen positive feedback on LH 72 hr and 2 the effect of aging on estrogen feedback on LH assessing negative feedback nadir 24 hr and positive feedback peak between 72 and 96 hr
Detailed Description: The transition to menopause is characterized by a decline in the numbers of functional ovarian follicles followed by a decrease in levels of inhibin A and B and complex changes in estradiol which include an initial increase followed by an inevitable decrease Therefore there are dynamic changes in the hypothalamic-pituitary feedback from the aging ovary prior to the ultimate loss of feedback that occurs with the complete cessation of ovarian function While there is ample evidence that the loss of ovarian function is a major contributor to the menopause there is evidence from animal models that primary age-related neuroendocrine changes may also contribute to reproductive aging Specifically there is evidence for changes in the hypothalamic and pituitary responses to estrogen negative and positive feedback An understanding of the age-related changes in the physiology of the hypothalamic and pituitary responsiveness to gonadal steroid feedback is critical in determining whether hypothalamic and pituitary changes per se contribute to the menopause and the impact of the loss of reproductive function on the brain

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01AG013241 NIH None httpsreporternihgovquickSearchR01AG013241