The Effects of Reproductive Hormones on Mood and Behavior
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|ClinicalTrials.gov Identifier: NCT00001322|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : August 6, 2020
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 or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Leuprolide Acetate 3.75 Drug: Estrogel Drug: Progesterone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement|
|Actual Study Start Date :||June 9, 1994|
|Actual Primary Completion Date :||March 3, 2020|
|Actual Study Completion Date :||March 3, 2020|
Lupron administration for 2 months
Drug: Leuprolide Acetate 3.75
Each woman will be administered Lupron for two months only.
After the first month of Lupron treatment when ovarian suppression has been achieved, we will administer 2-3 applications (approximately 6.0 9.0 mg estradiol gel (open label)) once a day for four weeks.
After the four weeks of estradiol treatment, all women will receive one week of progesterone suppositories (200 mg twice a day) to precipitate a progesterone withdrawal-induced menses.
- brain imaging measures including O15 PET [ Time Frame: ongoing ]brain imaging
- Dex/CRH stimulation tests [ Time Frame: Ongoing ]Dex/CRH tests
- metabolomic profile [ Time Frame: Ongoing ]metabolomic profile
- DNA for genotyping [ Time Frame: Ongoing ]genotyping
- cell culture studies (lymphoid and IPCs) [ Time Frame: Ongoing ]cell culture studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001322
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|