CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00060736
NCT00060736N/ACompleted

The Effects of Acute Withdrawal of Estradiol on Mood Symptoms in Women With Perimenopausal Depression

National Institute of Mental Health (NIMH)·observational·Posted May 12, 2003·Updated Dec 16, 2019

In Brief

An observational study for Perimenopausal Depression and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This study evaluates the effects on mood when stopping estrogen replacement therapy. The purpose of this study is to investigate the effects of estrogen levels on perimenopausal depression. This study will examine short-term withdrawal of estrogen in women whose mood had improved with estrogen therapy. Perimenopause-related mood disorders cause significant distress in a large number of women. Evidence suggests that estradiol may have beneficial effects in women with perimenopausal depression. However, the effect of declining estradiol secretion during perimenopause has not been fully examined. Peri- and post-menopausal women who experience a remission of perimenopause-related depression symptoms while on estrogen therapy and a control group of healthy volunteers on hormone replacement therapy (HRT) will be switched from their current form of HRT to estradiol for a 3-week period; volunteers will also complete symptom ratings to confirm the absence of mood symptoms. Participants will then be randomly assigned to either continue estradiol or take a placebo (an inactive pill) for an additional 3 weeks. Mood ratings will be used to determine response to estradiol withdrawal. ...

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2003
Enrollment StartMay 5, 2003
Study CompletionApr 27, 2016
TodayJul 2, 2026
Posted 23.1 years ago