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NCT04833140 · ClinicalTrials.gov registry record · Phase 3
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
A Phase 3 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04833140 is a Phase 3 study of NASH - Nonalcoholic Steatohepatitis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 267-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04833140, a Phase 3 study of NASH - Nonalcoholic Steatohepatitis, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Estradiol patch
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04833140
The ClinicalTrials.gov registry entry for NCT04833140 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 267-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (78% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04833140 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04833140 about?
NCT04833140 is a clinical study titled "Estrogen Administration for the Treatment of NASH in Postmenopausal Women". Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non...
What is the current status of trial NCT04833140?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2021-12-02. Estimated completion is 2027-05-31.
What conditions does trial NCT04833140 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04833140?
The interventions under investigation include: Placebo (DRUG), Estradiol patch (DRUG).
Who is sponsoring clinical trial NCT04833140?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04833140 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.