Actively Recruiting

Phase 1
Age: 18Years - 42Years
FEMALE
NCT05979389

Bicalutamide Therapy in Young Women With NAFLD and PCOS

Led by University of California, San Francisco · Updated on 2026-04-15

50

Participants Needed

1

Research Sites

232 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process. Such findings will provide the rationale for future efficacy studies evaluating selective androgen receptor (AR) antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity or lipid-specific pathways as part of a precision medicine approach to halt fibrosis progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain at increased risk for early onset and progressive liver disease.

CONDITIONS

Official Title

Bicalutamide Therapy in Young Women With NAFLD and PCOS

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 42 years with hyperandrogenic polycystic ovary syndrome (PCOS)
  • Nonalcoholic steatohepatitis (NASH) confirmed by liver biopsy or probable NASH based on transient elastography controlled attenuation parameter (CAP score 6270 dB/m and transient elastography score > 7.0 kPA) or alanine aminotransferase level 640 U/L
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes
  • Alcohol consumption exceeding 2 drinks per day for at least 3 consecutive months in the past 5 years
  • Other chronic liver diseases such as hepatitis B, hepatitis C, autoimmune hepatitis, or cirrhosis from any cause
  • Recent or planned weight reduction surgery within five years of NASH diagnosis
  • HIV infection
  • Use of drugs associated with fatty liver (e.g., amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks before baseline or during the study
  • Recent, current, or planned pregnancy or current perimenopausal status
  • Kidney impairment (glomerular filtration rate < 45 ml/min/1.73m or potassium levels > 5.0 mmol/L)
  • Use of androgen receptor antagonists (e.g., spironolactone or flutamide) for more than 3 months within one year before baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

L

Lily Carbullido

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Bicalutamide Therapy in Young Women With NAFLD and PCOS | DecenTrialz