Protocol Number: 92-M-0174

Title:

The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism with and without Estrogen and Progesterone Replacement

Number:

92-M-0174

Summary:

The purpose of this study is to evaluate the effect of the hormones progesterone and estrogen on women's mood, behavior, and mental functioning.

The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS.

This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088).

At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

INCLUSION CRITERIA

Between the ages of 18 and 45.

Subjects who are not pregnant.

Must be in good health.

Must be medication free.

EXCLUSION CRITERIA

Subjects taking birth control pills or diuretics.

Patients taking psychotropic agents (e.g., lithium carbinate, tricyclic antidepressants).

Controls must not have current or past axis I psychiatric diagnosis.

Must not have a history of menstrual-related mood or behavioral disturbances.

Special Instructions:

Call referral contact for additional eligibility criteria.

Keywords:

Gonadal Steroids

Mood

Menstrual Cycle

Neuropsychological Testing

Estrogen

Dexamethasone

Progesterone

Central Nervous System Function

Estradiol

GnRH Agonist

Recruitment Keywords:

None

Conditions:

Hypogonadism

Investigational Drug(s):

Lupron

Investigational Device(s):

None

Contacts:

Linda Simpson-St. Clair, R.N.
National Institutes of Health
Building 10
Room 3N238
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-9576
Fax: (301) 402-2588

Electronic Address: simpsonl@irp.nimh.nih.gov

Citations:

Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome

Chronic estrogen-induced alterations in adrenocorticotropin and corticosterone secretion, and glucocorticoid receptor-mediated functions in female rats

Modulation of cognition-specific cortical activity by gonadal steroids: a positron-emission tomography study in women

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/26/2004