Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001285
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects of Sex Hormones on Circadian Rhythm in Men and Women
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Chronobiologic Effects of Gonadal Steroid Manipulations in Volunteer Subjects
Status:
COMPLETED
Status Verified Date:
1999-10
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:
For many years researchers have been trying to better understand the regulation of sleep and activity by studying circadian daily rhythms of human beings It appears that the hormones estrogen progesterone and testosterone play a role in the regulation of circadian rhythm in animals Researchers believe these hormones may also play a similar role in the regulation of human circadian rhythms Little research has been conducted on how these hormones affect human circadian rhythms
This study is designed to learn more about how specific hormones influence men and womens daily rhythms This study will use women from another research study being conducted at the NIMH called The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone Male subjects will be recruited from another NIMH study called The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement
In order to test the possibility that gonadal steroids estrogen progesterone and testosterone change circadian rhythms and the sleep-wake cycle in humans participants will undergo chronobiologic evaluations The chronobiologic evaluations will look at sleep and rest periods activity as measured by a wrist monitor and 24 hour inpatient electroencephalograph EEG rectal temperature and melatonin monitoring
This study is designed to learn more about how specific hormones influence men and womens daily rhythms This study will use women from another research study being conducted at the NIMH called The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone Male subjects will be recruited from another NIMH study called The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement
In order to test the possibility that gonadal steroids estrogen progesterone and testosterone change circadian rhythms and the sleep-wake cycle in humans participants will undergo chronobiologic evaluations The chronobiologic evaluations will look at sleep and rest periods activity as measured by a wrist monitor and 24 hour inpatient electroencephalograph EEG rectal temperature and melatonin monitoring
Detailed Description:
It is hypothesized that gonadal steroids modulate circadian rhythms and the sleep-wake cycle in humans as they do in animals This hypothesis will be tested by performing chronobiologic evaluations on women enrolled in protocol 92-M-0174 The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without estrogen and progesterone and on men enrolled in protocol 94-M-0037 The central nervous system effects of pharmacologically induced hypogonadotropic hypogonadism with and without testosterone replacement Based on the animal literature we hypothesize that melatonin and sleep onset will be phase-advanced in women on estrogen compared with those on progesterone or in a hypogonadal state We also hypothesize that the amplitude of the activity cycle will be decreased in the progesterone as compared with the estrogen condition Based on findings in amenorrheic women and in those on oral contraceptives we hypothesize that the amplitude of melatonin secretion will be increased in the hypogonadal state compared with the other two conditions Finally based on literature cited below we hypothesize that mean prolactin levels will be higher in the testosterone plus Lupron condition and in the estrogen plus Lupron condition than in the other hormonal conditions
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 |
|---|---|---|---|
| 91-M-0206 | None | None | None |