Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001412
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement
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 Testosterone Replacement
Status:
COMPLETED
Status Verified Date:
2001-11
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:
There is evidence that suggests male sex hormones androgens play a significant role in brain central nervous system functioning In studies conducted with animals researchers have documented that male sex hormones androgens are associated with neurotransmitter serotonin function sexual behavior aggression and other non-reproductive behavior Similar findings have been seen in studies involving humans
Androgens are thought to be involved in some neurologic conditions Tourettes syndrome which is seen more often in males than females has caused researchers to look more closely at the effects of androgens on the brain
This study is designed to examine the effects of testosterone on brain CNS activity by first stopping testosterone release and then replacing it
Researchers will evaluate mood behavior cognitive mental function physiologic response to serotonergic agonists and regional cerebral blood flow r-CBF
This study will attempt to answer the following questions
1 Is a persons mental functioning a result of being male or female gender or a result of the hormonal condition
3 Does the decrease of blood flow r-CBF to specific areas of the brain prefrontal cortex in women whose ovaries are not releasing hormones hypogonadal state also occur in men
4 Will the mental rotation task better identify hormone gonadal steroid differences in r-CBF
5 Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal HPA axis
6 Does the hormonal state of a patient directly affect levels of chemicals and steroids in the cerebrospinal fluid CSF
Androgens are thought to be involved in some neurologic conditions Tourettes syndrome which is seen more often in males than females has caused researchers to look more closely at the effects of androgens on the brain
This study is designed to examine the effects of testosterone on brain CNS activity by first stopping testosterone release and then replacing it
Researchers will evaluate mood behavior cognitive mental function physiologic response to serotonergic agonists and regional cerebral blood flow r-CBF
This study will attempt to answer the following questions
1 Is a persons mental functioning a result of being male or female gender or a result of the hormonal condition
3 Does the decrease of blood flow r-CBF to specific areas of the brain prefrontal cortex in women whose ovaries are not releasing hormones hypogonadal state also occur in men
4 Will the mental rotation task better identify hormone gonadal steroid differences in r-CBF
5 Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal HPA axis
6 Does the hormonal state of a patient directly affect levels of chemicals and steroids in the cerebrospinal fluid CSF
Detailed Description:
Several types of evidence suggest that androgens exert clinically significant effects on central nervous system CNS function In animal studies androgens modulate brain serotonin function and regulate sexual behavior aggression and other non-reproductive behaviors These actions reflect both organizational and activational effects of androgens Several studies in humans also support the central modulatory capacity of androgens Correlative studies have described relationships between plasma androgen levels and sexual interestbehavior and cognitive task performance Androgens are believed to underlie gender related differences in the prevalence of certain neuropsychiatric disorders resulting in trials of anti-androgens in at least one of these disorders Tourettes syndrome Finally androgens are believed to possess psychotropic effects in humans evidenced by purported antidepressant effects and reports of psychotic reactions following administration of androgens In a recent study we demonstrated that androgenicanabolic steroids precipitated mood and behavioral state disturbances when administered in a double-blind placebo-controlled fashion in normal volunteers There are remarkably few studies that attempt to identify the CNS effects of androgens or the central systems that may mediate these effects In this study we propose to examine directly the effects of testosterone on CNS activity by first suppressing and then in a double-blind placebo-controlled fashion replacing physiological levels of testosterone We will evaluate mood behavior cognitive function physiologic response to serotonergic agonists and cerebral blood flow separate protocols during both pharmacologically controlled hormonal conditions hypogonadism and hypogonadism with testosterone replacement On the basis of prior findings from our group and from others we will be asking the following questions 1 Does cognitive function differ as a function of gender or of hormonal condition 2 Is the decreased r-CBF that we observed in the prefrontal cortex during the hypogonadal state in women also demonstrable in men 3 Do measures of hypothalamic-pituitary-adrenal axis responsivity differ as a function of gender or of hormonal condition and 4 Do CSF neurochemistry and neurosteroid levels differ as a consequence of changing hormonal state This protocol will not only provide much needed information about the behavioral and physiological effects of androgens but will serve as a companion study for NIMH protocol 92-M-172 The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism with and without Estrogen and Progressive Replacement
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 |
|---|---|---|---|
| 94-M-0037 | None | None | None |