Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement

NCT00001412 | Completed

• 2 other identifiers: 94003794-M-0037
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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. 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

Hypogonadism

Keywords

Gonadal Steroids; Central Nervous System Function; GnRH Agonist; Testosterone; Leuprolide Acetate; Mood; Behavior; Cognitive Function

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Age 18-45. Males. No current mood symptoms. No past psychiatric history. Not taking ongoing medications. No medical illnesses.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Rubinow DR, Schmidt PJ. Androgens, brain, and behavior. Am J Psychiatry. 1996 Aug;153(8):974-84. doi: 10.1176/ajp.153.8.974.

  PMID: 8678193 BACKGROUND

• Handa RJ, Burgess LH, Kerr JE, O'Keefe JA. Gonadal steroid hormone receptors and sex differences in the hypothalamo-pituitary-adrenal axis. Horm Behav. 1994 Dec;28(4):464-76. doi: 10.1006/hbeh.1994.1044.

  PMID: 7729815 BACKGROUND

• Su TP, Pagliaro M, Schmidt PJ, Pickar D, Wolkowitz O, Rubinow DR. Neuropsychiatric effects of anabolic steroids in male normal volunteers. JAMA. 1993 Jun 2;269(21):2760-4.

  PMID: 8492402 BACKGROUND

MeSH Terms

Conditions

Hypogonadism; Behavior

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: December 1, 1993
• Study Completion: November 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-11

Locations

US (1)