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NCT00001770 · ClinicalTrials.gov registry record
Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 50
- Enrollment target
NCT00001770 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 50 participants.
The verdict
NCT00001770 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
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?
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1998-03 |
| Est. Completion | 2003-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001770
The ClinicalTrials.gov registry entry for NCT00001770 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00001770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001770 about?
NCT00001770 is a clinical study titled "Progestin (Progesterone-Like Hormones) Induced Dysphoria (Depressed Mood, Irritability, Anxiety)". 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 ...
What is the current status of trial NCT00001770?
This trial is currently completed. The enrollment target is 50 participants. The study started on 1998-03. Estimated completion is 2003-03.
Who is sponsoring clinical trial NCT00001770?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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