Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351416
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2006-07-10
Brief Title:
Letrozole Treatment in Normal and GnRH Deficient Women
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Letrozole Treatment in Normal and GnRH Deficient Women
Status:
UNKNOWN
Status Verified Date:
2017-06
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:
This research study involves the use of the drugs Letrozole GnRH and NAL-GLU GnRH antagonist Letrozole is a drug that is approved by the US Food and Drug Administration FDA for use in breast cancer treatment that has been found to block the formation of estrogen The NAL-GLU GnRH antagonist is a drug that temporarily blocks the action of GnRH GnRH is a hormone that the body makes that stimulates other hormones that then control the function of the ovary
The purpose is to study the effects of the administration of letrozole in women with GnRH deficiency at the same time that they receive gonadotropin-releasing hormone GnRH In addition administration of letrozole and NAL-GLU GnRH antagonist in healthy women with normal menstrual cycles will be done to evaluate the role of estrogen in the control of the hormone FSH or Follicle Stimulating Hormone in the female reproductive cycle A better understanding of FSH control may help in the development of new treatments for women with difficulty conceiving
The purpose is to study the effects of the administration of letrozole in women with GnRH deficiency at the same time that they receive gonadotropin-releasing hormone GnRH In addition administration of letrozole and NAL-GLU GnRH antagonist in healthy women with normal menstrual cycles will be done to evaluate the role of estrogen in the control of the hormone FSH or Follicle Stimulating Hormone in the female reproductive cycle A better understanding of FSH control may help in the development of new treatments for women with difficulty conceiving
Detailed Description:
The negative feedback control of FSH is crucial for the precise regulation of follicular development in the female An important component of this feedback is exerted by estrogen Letrozole will be used to block aromatase and therefore estradiol production in normal and GnRH deficient females These studies will dissect the relative roles of estradiol and inhibin on FSH secretion at the pituitary and hypothalamus
The aromatase inhibitors block aromatization of androgens to estrogens allowing us to examine the relative contribution of estradiol and the inhibins to FSH regulation The use of a submaximal dose of a GnRH antagonist will allow us to estimate the overall amount of GnRH secreted hypothalamic contribution with and without aromatase inhibition
A more thorough understanding of estrogen and inhibin feedback on FSH will improve our understanding of the failure of follicle development in subsets of patients with infertility such as polycystic ovary syndrome in which FSH levels are normal but follicles fail to develop Study of FSH control will also help us understand the failure of negative feedback on FSH which can result in multiple follicular development and multiple gestation and its associated costs and risks Thus these studies may afford new therapeutic options for conception in infertile patients while simultaneously providing new methods to avoid the risks of multiple gestations
The aromatase inhibitors block aromatization of androgens to estrogens allowing us to examine the relative contribution of estradiol and the inhibins to FSH regulation The use of a submaximal dose of a GnRH antagonist will allow us to estimate the overall amount of GnRH secreted hypothalamic contribution with and without aromatase inhibition
A more thorough understanding of estrogen and inhibin feedback on FSH will improve our understanding of the failure of follicle development in subsets of patients with infertility such as polycystic ovary syndrome in which FSH levels are normal but follicles fail to develop Study of FSH control will also help us understand the failure of negative feedback on FSH which can result in multiple follicular development and multiple gestation and its associated costs and risks Thus these studies may afford new therapeutic options for conception in infertile patients while simultaneously providing new methods to avoid the risks of multiple gestations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| Sundry Department Fund | OTHER | MGH-REU Department Fund | None |