Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001322
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
1999-11-03
Brief Title:
The Effects of Reproductive Hormones on Mood and Behavior
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement
Status:
COMPLETED
Status Verified Date:
2021-02-25
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:
This study evaluates the effects of estrogen and progesterone on mood the stress response and brain function in healthy women
The purpose of this study is to evaluate how low levels of estrogen and progesterone that occur during treatment with leuprolide acetate compare to menstrual cycle levels of estrogen and progesterone given during individual months of hormone add-back on a variety of physiologic measures brain imaging stress testing etc in healthy volunteer women without PMS
This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving in sequence the menstrual cycle hormones progesterone and estrogen Tests such as brain imaging or stress testing etc will be performed during the different hormonal conditions low estrogen and progesterone progesterone add-back estrogen add-back The results of these studies will be compared between women without PMS and women with PMS see also protocol 90-M-0088
At study entry participants will undergo a physical examination Blood urine and pregnancy tests will be performed Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies
The purpose of this study is to evaluate how low levels of estrogen and progesterone that occur during treatment with leuprolide acetate compare to menstrual cycle levels of estrogen and progesterone given during individual months of hormone add-back on a variety of physiologic measures brain imaging stress testing etc in healthy volunteer women without PMS
This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving in sequence the menstrual cycle hormones progesterone and estrogen Tests such as brain imaging or stress testing etc will be performed during the different hormonal conditions low estrogen and progesterone progesterone add-back estrogen add-back The results of these studies will be compared between women without PMS and women with PMS see also protocol 90-M-0088
At study entry participants will undergo a physical examination Blood urine and pregnancy tests will be performed Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies
Detailed Description:
Evidence suggests that the gonadal steroids may exert clinically significant effects on central nervous system function For example the menstrual cycle may influence the occurrence of seizures in some female epileptics and the performance on certain cognitive tests Central nervous system effects of gonadal steroids have been inferred largely from changes in behavior occurring in association with presumed changes in gonadal steroids during the normal menstrual cycle during the administration of ovarian hormones or in a gender-specific context These inferences are by definition indirect and associational in nature and further are incapable of disentangling the effects of hormones which are simultaneously present in women of reproductive age This study is designed to address those problems by comparing measures during Lupron-induced hypogonadism with those during replacement with estrogen or progesterone On the basis of prior findings from our group and from others we will be asking the following questions 1 Is the decreased r-CBF that we observed in the prefrontal cortex during the hypogonadal state confirmed in individual women using new imaging techniques 2 Will variation in genotype eg COMT valmet BDNF valmet confer differential sensitivity to ovarian steroids in brain circuitry and 3 Are the menstrual cycle phase-related changes in reward systems that we previously observed related to estradiol or progesterone actions within the brain 1 Additionally this protocol will serve as a control study for protocol 90-M-0088
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 |
|---|---|---|---|
| 92-M-0174 | None | None | None |