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NCT00001412 · ClinicalTrials.gov registry record
Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement
A clinical trial of Hypogonadism, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 70
- Enrollment target
- 1
- Study location
NCT00001412 is a study of Hypogonadism that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 70 participants, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001412, a study of Hypogonadism, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
- 1
- Study location
Study 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. Tourette's 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 person's 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).
Conditions Studied
Study Locations (1)
Maryland
- National Institute of Mental Health (NIMH) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 1993-12 |
| Est. Completion | 2001-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001412
The ClinicalTrials.gov registry entry for NCT00001412 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (40% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 0 interventions.
NCT00001412 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001412 about?
NCT00001412 is a clinical study titled "Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement". 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 beh...
What is the current status of trial NCT00001412?
This trial is currently completed. The enrollment target is 70 participants. The study started on 1993-12. Estimated completion is 2001-11.
What conditions does trial NCT00001412 study?
This clinical trial studies the following conditions: Hypogonadism.
Who is sponsoring clinical trial NCT00001412?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001412 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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