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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001322 |
Purpose
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.
| Condition |
|---|
|
Hypogonadism |
| Study Type: | Observational |
| Official Title: | The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 1992 |
Evidence suggests that the gonadal steroids may exert clinically significant effects on central nervous system function. For example, the menstrual cycle may influence the occurrence of seizures in some female epileptics and the performance on certain cognitive tests. Central nervous system effects of gonadal steroids have been inferred largely from changes in behavior occurring in association with presumed changes in gonadal steroids during the normal menstrual cycle, during the administration of ovarian hormones, or in a gender-specific context. These inferences are, by definition, indirect and associational in nature and further are incapable of disentangling the effects of hormones which are simultaneously present in women of reproductive age. This study is designed to address those problems by comparing measures during Lupron-induced hypogonadism with those during replacement with estrogen or progesterone. On the basis of prior findings from our group and from others, we will be asking the following questions: 1) Does cognitive function differ as a function of gender (in concert with protocol # 94-M-0037) or of hormonal condition; 2) Is the decreased r-CBF that we observed in the prefrontal cortex during the hypogonadal state confirmed in individual women using new imaging techniques; 3) Will the mental rotation task, a sexually dimorphic cognitive task, better identify gonadal steroid related differences in brain r-CBF than tests of working memory; 4) Are the menstrual cycle phase-related changes in reward systems that we previously observed related to estradiol or progesterone actions within the brain and 5) Do measures of hypothalamic-pituitary-adrenal axis responsivity differ as a function of hormonal condition. Additionally, this protocol will serve as a control study for protocol # 90-M-0088 and a companion protocol for # 94-M-0037.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: Peter J. Schmidt, M.D. | (301) 496-6120 | PeterSchmidt@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| ClinicalTrials.gov Identifier: | NCT00001322 History of Changes |
| Other Study ID Numbers: | 920174, 92-M-0174 |
| Study First Received: | November 3, 1999 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Federal Government |
|
Gonadal Steroids Mood Menstrual Cycle Neuropsychological Testing Estrogen |
Dexamethasone Progesterone Central Nervous System Function Estradiol GnRH Agonist |
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Estrogens Progesterone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Progestins |
