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NCT03576755 · ClinicalTrials.gov registry record · Phase 1
Spironolactone Therapy In Young Women With NASH
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03576755: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT03576755 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03576755, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. The investigator's preliminary data support a detrimental role of androgens, or "male sex hormones" on fatty liver in women but no studies have evaluated whether androgens are associated with liver inflammation and/or scarring from fatty liver (aka NASH). To better understand the mechanism by which androgens might promote NASH and/or metabolic co-factors that contribute to NASH, the investigators are conducting a pilot clinical trial to primarily assess the feasibility of using an androgen blocking medication, spironolactone, in women with NASH. Spironolactone was selected because it is has been commonly prescribed for decades with good safety profile and tolerability to treat symptoms of high androgens, like acne and hirsutism in young women. Though primarily a feasibility-focused study, the investigators also aim to explore the pathways by which blocking testosterone receptors might alter the biologic processes that promote NASH and its associated metabolic co-morbidities in women.
Primary Outcome
The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)
Interventions
- DRUG Placebo oral capsule
- DRUG Spironolactone 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 1 |
What the finished NCT03576755 record still lists
NCT03576755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03576755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03576755 about?
NCT03576755 is a clinical study titled "Spironolactone Therapy In Young Women With NASH". Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urg...
What is the current status of trial NCT03576755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-01-09. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT03576755?
The interventions under investigation include: Placebo oral capsule (DRUG), Spironolactone 100mg (DRUG).
Who is sponsoring clinical trial NCT03576755?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03576755's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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