Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)
Completed
Conditions studied: Depressive Disorder, Mood Disorder, Psychomotor Agitation
In brief
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?
Key facts
- Study ID
- NCT00001770
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 50
- Starts
- 1998-03-01
- Expected to finish
- 2003-03-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- The subjects in this study will be women who meet the following criteria:
- history of mood and/or behavioral symptoms associated with hormone replacement therapy;
- age 40 to 65;
- in good medical health.
You may not qualify if…
- 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.
Where it is running
- National Institute of Mental Health (NIMH) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.