Combined Hormone Replacement in Menstrually-Related Mood Disorders
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|ClinicalTrials.gov Identifier: NCT00005011|
Recruitment Status : Completed
First Posted : March 30, 2000
Last Update Posted : February 23, 2018
This study investigates the effects on symptoms of combined treatment with estrogen and progesterone in women with severe premenstrual syndrome (PMDD).
Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but not women without the disorder, experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone. The cause of this hormone-induced depression remains unclear. It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone. This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS.
Participants in this study will receive leuprolide acetate injections once a month for up to 6 months. After 2 months, women whose symptoms have improved will receive a skin patch containing either estrogen or placebo (an inactive substance) and will be asked to take daily suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels.
|Condition or disease|
|Premenstrual Syndrome Depression|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||The Treatment of Menstrually-Related Mood Disorders With Continuous Gonadal Steroid Replacement|
|Study Start Date :||March 28, 2000|
|Estimated Study Completion Date :||October 28, 2016|
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): NCT00005011
|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)|