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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 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03576755
The ClinicalTrials.gov registry entry for NCT03576755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03576755 reports 0 study locations.
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.
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