Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	92-M-0174
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Female Min Age: 18 Max Age: 50
Referral Letter Required	No
Population Exclusion(s)	Male; Children
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 Keyword(s)	None
Condition(s)	Hypogonadism
Investigational Drug(s)	Leuprolide Acetate 3.75 mg Depot Lupron
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Mental Health

This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women.

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.

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Eligibility

INCLUSION CRITERIA:

Volunteers participating in this study will be women between the ages of 18 and 50 years,

Not pregnant,

In good medical health,

Medication free,

No history of menstrual-related mood or behavioral disturbances.

EXCLUSION CRITERIA:

The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol:

Current Axis I psychiatric diagnosis (with the exception of this women with a past major depression who will be studied on this protocol);

History consistent with endometriosis;

Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement;

Hepatic disease as manifested by abnormal liver function tests;

History of mammary carcinoma;

History of pulmonary embolism or phlebothrombosis;

Undiagnosed vaginal bleeding;

Porphyria;

Diabetes mellitus;

History of malignant melanoma;

Cholecystitis or pancreatitis;

Cardiovascular or renal disease;

Pregnancy;

Subjects taking birth control pills will be excluded from the study.

Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study, as will patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants).

All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study.

Participants who have an active condition that places them at an increased risk for osteoporosis will be excluded from this protocol.

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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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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Peter J. Schmidt, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 6A02 10 Center Drive Bethesda, Maryland 20892 (301) 402-4559 sm221a@nih.gov	Peter J. Schmidt, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 8N246 10 Center Drive Bethesda, Maryland 20892 (301) 435-8003 heytensl@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001322

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