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Anti-Androgen

Spironolactone 100mg for Non-alcoholic Fatty Liver Disease

Phase 1 & 2
Waitlist Available
Led By Monika A Sarkar
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 or 12 months
Awards & highlights

Study Summary

This trial is looking at whether androgens, or "male sex hormones" play a role in NASH in women. NASH is a fat-related liver inflammation and scarring that is projected to be the leading cause of cirrhosis in the United States. Spironolactone, an androgen blocking medication, will be used to see if it has an effect on NASH. The study is primarily focused on feasibility, but will also explore how blocking testosterone receptors might alter the biologic processes that promote NASH in women.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 or 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 or 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in liver stiffness on Magnetic Resonance Elastography (MRE)
Secondary outcome measures
Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR)).
Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
Change in the NAFLD activity score (NAS 0-8).
+1 more

Side effects data

From 2017 Phase 2 & 3 trial • 20 Patients • NCT02585843
10%
Hyperkalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-dose
Standard of Care

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: spironolactoneExperimental Treatment1 Intervention
spironolactone, 100 mg capsule administered orally once daily for 6 or 12 months
Group II: placeboPlacebo Group1 Intervention
matching placebo capsule administered orally once daily for 6 or 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,778 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
4,112 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Monika A SarkarPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must prospective participants meet to take part in this experiment?

"To be deemed eligible for this trial, candidates must have been diagnosed with nonalcoholic steatohepatitis and fall between the ages of 18-45. The team is looking to recruit a total of 30 participants."

Answered by AI

Does this medical trial take into consideration participants aged under thirty?

"The study is seeking participants who are within the ages of 18 and 45."

Answered by AI

Are there still opportunities to join this experiment?

"Indeed, clinicaltrials.gov reveals that the trial is currently enrolling participants and was originally listed on January 9th 2019. As of September 9 2022, 30 people from a single medical centre are needed for participation."

Answered by AI

What is the total size of the patient cohort in this research endeavor?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which was initially posted on January 9th 2019, is actively seeking participants. 30 patients need to be enrolled at a single medical centre for the study's completion."

Answered by AI

What are the chief indications for Spironolactone 100mg?

"Spironolactone 100mg is a standard medication for primary hyperaldosteronism. Additionally, it has proven successful at treating cirrhosis of the liver, therapeutical procedures, and acne."

Answered by AI

Has Spironolactone 100mg been the focus of prior research endeavors?

"At this time, 28 medical trials are in progress that explore the effects of Spironolactone 100mg. Of those studies, 7 are at Phase 3 and 293 different sites across the world have begun to experiment with this medication. The majority of these experiments take place in Boston, Massachusetts."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025