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Search/NCT00001770
NCT00001770N/ACompleted

The Phenomenology and Biophysiology of Progestin-Induced Dysphoria

National Institute of Mental Health (NIMH)·observational·Posted Nov 4, 1999·Updated Mar 4, 2008

In Brief

An observational study for Depressive Disorder and 2 related conditions. Completed, across 1 site.

Detailed Summary

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: 1. Are progestins associated with changes in mood during hormone replacement therapy? 2. If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?

Study Details

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

Timeline

N/ACompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartMar 1, 1998
Study CompletionMar 1, 2003
TodayJul 2, 2026
Posted 26.7 years ago