Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)
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|ClinicalTrials.gov Identifier: NCT00001770|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause.
Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk of uterine cancer. The progesterone component of the HRT (progestin) works to prevent the increased risk of uterine cancer.
There is evidence that some women experience unpleasant mood symptoms (such as irritability, depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking the progestin / progesterone component of the HRT.
This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women. Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home.
This research will attempt to answer the following questions:
- Are progestins associated with changes in mood during hormone replacement therapy?
- If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
|Condition or disease|
|Depressive Disorder Mood Disorder Psychomotor Agitation|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Phenomenology and Biophysiology of Progestin-Induced Dysphoria|
|Study Start Date :||March 1998|
|Estimated Study Completion Date :||March 2003|
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): NCT00001770
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|