MedTrace Logo

Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)

NCT00001770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2008-03-04

No results posted yet for this study

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?

Conditions

  • Depressive Disorder
  • Mood Disorder
  • Psychomotor Agitation

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-03-31
Completion
2003-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001770 on ClinicalTrials.gov