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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001770 |
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Date of registration:
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03/11/1999 |
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Primary sponsor: |
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Public title:
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Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)
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Scientific title:
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The Phenomenology and Biophysiology of Progestin-Induced Dysphoria |
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Date of first enrolment:
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March 1998 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001770 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA
The subjects in this study will be women who meet the following criteria:
1. history of mood and/or behavioral symptoms associated with hormone replacement
therapy;
2. age 40 to 65;
3. in good medical health.
EXCLUSION CRITERIA
Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not
participate in this protocol. Additionally prior to participation all subjects will be
examined for any contradictions to estrogen therapy (as determined by a pelvic exam and
mammogram) within the past year by a gynecologist of their choice. In those patients who
are unable to independently arrange this exam, we have arranged for a consultant
gynecologist to be available through our collaboration with NICHD.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Depressive Disorder
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Mood Disorder
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Psychomotor Agitation
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Secondary ID(s)
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98-M-0079
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980079
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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