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The Effects of Reproductive Hormones on Mood and Behavior
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2008
Sponsored by: 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

MedlinePlus related topics: Menstruation
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Progesterone Gonadorelin Gonadorelin hydrochloride LH-RH
U.S. FDA Resources
Study Type: Observational
Official Title: The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: April 1992
Detailed Description:

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; and 4) 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 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • ELIGIBILITY CRITERIA:

Volunteers participating in this study will be women between the ages of 18 and 55 years, not pregnant, in good medical health, medication free, and who have no history of menstrual-related mood or behavioral disturbances. The absence of menstrual-related mood disorders will be prospectively confirmed during a two month period prior to the study entry when subjects will complete daily visual analogue rating scales monitoring both mood and behavior as outlined in NIMH protocol # 81-M-0126. 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.

The Structured Clinical Interview for DSM-IV will be administered to controls prior to study entry. Any control with a current or past axis I psychiatric diagnosis will be excluded from participating in this protocol (except in the subgroup of asymptomatic women with a past major depressive episode who participate in this protocol).

Subjects taking birth control pills or diuretics will 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.

The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol: 1) history consistent with endometriosis; 2) diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement; 3) hepatic disease as manifested by abnormal liver function tests; 4) history of mammary carcinoma; 5) history of pulmonary embolism or phlebothrombosis; 6) undiagnosed vaginal bleeding; 7) porphyria; 8) diabetes mellitus; 9) history of malignant melanoma; 10) cholecystitis or pancreatitis; 11) cardiovascular or renal disease; 12) pregnancy; and 13) a past or current Axis I psychiatric illness (with the exception of those women with a past major depression who will be studied in this protocol). Further, subjects will be warned not to become pregnant during the study and will be required to employ barrier contraceptive methods. Finally, participants who have an active condition that places them at an increased risk for osteoporosis will be excluded from this protocol.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001322

Contacts
Contact: Linda Simpson-St. Clair, R.N. (301) 496-9576 simpsonl@irp.nimh.nih.gov
Contact: Peter J. Schmidt, M.D. (301) 496-6120 PeterSchmidt@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 920174, 92-M-0174
Study First Received: November 3, 1999
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00001322  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gonadal Steroids
Mood
Menstrual Cycle
Neuropsychological Testing
Estrogen
Dexamethasone
Progesterone
Central Nervous System Function
Estradiol
GnRH Agonist

Study placed in the following topic categories:
Dexamethasone
Progesterone
Gonadal Disorders
Estradiol valerate
Endocrine System Diseases
Estradiol 17 beta-cypionate
Estradiol
Deslorelin
Hypogonadism
Estradiol 3-benzoate
Endocrinopathy
Polyestradiol phosphate
Dexamethasone acetate

Additional relevant MeSH terms:
Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009