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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: Completed study of Hypogonadism, sponsored by National Institute of Mental Health (NIMH).

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 70 participants
Start Date 1993-12
Est. Completion 2001-11

What the finished NCT00001412 record still lists

NCT00001412 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 117-participant average among 21 other Hypogonadism trials with a reported enrollment target (40% lower).

The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 0 interventions.

NCT00001412 reports a single indexed study location in 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.

Similar trials for Hypogonadism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00001412's enrollment target sits among peer trials

70 11th of 21 higher than 11 of 21 other Hypogonadism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypogonadism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001412, the US trial registry maintained by the National Library of Medicine. NCT00001412 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.