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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: Recruiting Phase 3 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Massachusetts General Hospital.
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 260-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in percentage of hepatic fat
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 |
What NCT04833140 shows while recruiting
NCT04833140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 260-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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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Where NCT04833140's enrollment target sits among peer trials
60 19th of 28 higher than 9 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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