Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386022
Status:
UNKNOWN
Last Update Posted:
2017-04-13
First Post:
2006-10-06
Brief Title:
The Effects of Aging and Estrogen on the Pituitary
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Effect of Aging on the Isolated Pituitary Response to Gonadotropin Releasing Hormone at Baseline and With Low Dose Estrogen Administration
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 this study is to study the effects of aging and estrogen on the brain Specifically this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging
Detailed Description:
Although it is clear that loss of ovarian function plays a major role in the menopause in women there is evidence from animal studies that primary age-related hypothalamic and pituitary changes may also contribute to reproductive aging Complete cessation of ovarian function results in the loss of negative feedback of ovarian steroids and inhibin on the hypothalamic and pituitary components of the reproductive axis An increase in serum levels of luteinizing hormone LH and follicle-stimulating hormone FSH occurs in postmenopausal women with removal of negative ovarian feedback However levels of LH and FSH after menopause decline steadily as a function of age in most though not all studies
The current study is designed to determine 1 whether negative feedback on LH and FSH occurs at the pituitary and 2 whether there is an effect of aging on estrogen negative feedback at the pituitary Younger and older postmenopausal women underwent a baseline study and a second identical study after a month of low dose estrogen replacement The study protocol consisted of the following 1 administration of a GnRH antagonist Nal-Glu at 150 mgkg that blocks endogenous GnRH so that the dose and interval of pituitary exposure to GnRH are precisely controlled 2 beginning 8 hours following GnRH antagonist administration at a time when LH had reached its nadir following GnRH receptor blockade administration of 4 graded doses of GnRH 25 75 250 and 750 ngkg every 2 hours with 2 hours of blood draws following each dose Blood was sampled every 30 min for 4 hours before antagonist administration every 30 min for the following 7 hours and then every 10 min until the completion of the study
The current study is designed to determine 1 whether negative feedback on LH and FSH occurs at the pituitary and 2 whether there is an effect of aging on estrogen negative feedback at the pituitary Younger and older postmenopausal women underwent a baseline study and a second identical study after a month of low dose estrogen replacement The study protocol consisted of the following 1 administration of a GnRH antagonist Nal-Glu at 150 mgkg that blocks endogenous GnRH so that the dose and interval of pituitary exposure to GnRH are precisely controlled 2 beginning 8 hours following GnRH antagonist administration at a time when LH had reached its nadir following GnRH receptor blockade administration of 4 graded doses of GnRH 25 75 250 and 750 ngkg every 2 hours with 2 hours of blood draws following each dose Blood was sampled every 30 min for 4 hours before antagonist administration every 30 min for the following 7 hours and then every 10 min until the completion of the study
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 |