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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

92-M-0174

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 18
Max Age: 50

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Behavior;
Brain Function;
Progesterone;
Central Nervous System Function;
GnRH Agonist

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers

Investigational Drug(s)

Leuprolide Acetate 3.75 mg Depot Lupron
Estrogel

Investigational Device(s)

None

Intervention(s)

Drug: Leuprolide Acetate 3.75
Drug: Estrogel
Drug: Progesterone
Drug: Placebo suppository
Drug: Placebo patch

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 meeting the following criteria:

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.

Additionally, we will recruit a subsample of 20 asymptomatic women who will meet all inclusion and exclusion criteria in this protocol except they will have a history of a past major depressive episode.

Finally, a third sample of 10 women who meet all the inclusion and exclusion criteria listed above for this protocol will be recruited to establish the dose range of transdermal estrogen gel for this and related protocols (i.e., 90-M-0088 and 05-M-0059).

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;

Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause (129). Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (greater than or equal to 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.

National Institute of Mental Health (NIMH) employees/staff and their immediate family members will be excluded from the study per NIMH policy.

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:

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001322

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