The NIH is currently seeking healthy male volunteers to help researchers undertand if there is a link between male sex hormones and central nervous system functioning. With Androgel, Viagra and Uprima on the market, more information is needed in order to better understand male hormonal physiology. If you have patients asking about Androgel or the effects of testosterone throughout the aging process, the clinical research study outlined below may be of some interest.

Title: The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism with and without Testosterone Replacement

Number: 94-M-0037

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, phsyiologic 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

2. 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

3. Will the mental rotation task better identify hormone (gonadal steroid) differences in r-CBF

4. Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal (HPA) axis

5. Does the hormonal state of a patient directly affect levels of chemicals and steroids in the cerebrospinal fluid (CSF).

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Eligibility Criteria:

Age 18-45.

Males.

No current mood symptoms.

No past psychiatric history.

Not taking ongoing medications.

No medical illnesses.

Special Instructions: Currently Not Provided

Disease Category:

Endocrine, Nutritional, Metabolic, & Immunity

Keywords:

Gonadal Steroids

Central Nervous System Function

GnRH Agonist

Testosterone

Leuprolide Acetate

Mood

Behavior

Cognitive Function

Recruitment Keywords:

None

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office, CC.
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Long Distance Calls: 1-800-411-1222
Fax: (301) 480-9793
Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Rubinow. 1996. Androgens, brain and behavior, Am J Psychiatry, Vol. 153, p. 974

Handa. 1994. Gonadal steroid hormone receptors and sex differences in the hypothalamo-pituitary-adrenal axis, Horm Behav, Vol. 28, p. 464

Su. 1993. Neuropsychiatric effects of anabolic steroids in male normal volunteers, JAMA, Vol. 269, p. 2760

If you have:

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Questions about specific studies, or the database in general, please contact the Protocol Coordination Service Center, CC.
• Technical questions regarding the Clinical Center web site, please contact the Information Systems Department, CC.

For more information on similar studies or other clinical research, please try one of these links:
Clinical Center Home
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