Actively Recruiting

Phase 1
Age: 18Years - 42Years
FEMALE
ID05979389

Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)

Led by University of California, San Francisco · Updated on 2026-05-29

50

Participants Needed

1

Research Sites

N/A

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), a liver condition involving fat-related inflammation and scarring, is expected to become the leading cause of cirrhosis in the U.S. Women with polycystic ovary syndrome (PCOS) are at higher risk for NASH, affecting about 15 million U.S. women. This research aims to study how androgens contribute to liver damage and disease progression in women with PCOS and explore the role of lipid metabolism and visceral fat in this process. The results may guide future treatments targeting these factors to slow liver fibrosis in young women with PCOS and NAFLD. This clinical trial is a single-center, double-blind, placebo-controlled pilot study involving 50 women with biopsy-proven or likely NAFLD. Participants will be randomly assigned to receive either 50 mg of bicalutamide or a matching placebo capsule once daily for 6 months. In-person visits will occur monthly for six months, followed by a telephone follow-up within one month after treatment ends. This study focuses on evaluating feasibility and various liver-related outcomes. Participants will undergo assessments including magnetic resonance elastography to measure liver stiffness, magnetic resonance imaging for visceral fat volume, and proton density fat fraction to assess liver fat at the start and after 6 months. Liver biopsies will be evaluated to track changes in NASH activity, and blood tests will measure insulin resistance and lipid levels. Researchers will also monitor reasons for study dropout and participation rates. The total participation period is about 7 months including treatment and follow-up.

CONDITIONS

Brief 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...

  • Women aged 18 to 42 years with hyperandrogenic polycystic ovary syndrome (PCOS)
  • NASH confirmed by liver biopsy or likely NASH based on transient elastography and liver enzyme tests
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes
  • Alcohol use exceeding 2 drinks per day for 3 or more consecutive months in the past 5 years
  • Other chronic liver diseases or cirrhosis from any cause
  • Recent or planned weight loss surgery within 5 years of NASH diagnosis
  • HIV infection
  • Use of drugs linked to fatty liver for more than 4 weeks before or during the study
  • Recent, current, or planned pregnancy or perimenopausal status
  • Kidney impairment with low filtration rate or high potassium levels
  • Use of androgen receptor antagonists for more than 3 months within the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants take a daily dose of bicalutamide or placebo for 6 months while undergoing monthly in-person evaluations.

6 monthly visits (in-person)

Follow-up

Duration - Up to 1 month

Participants have a telephone follow-up visit within one month after finishing treatment to check on their status.

1 telephone visit

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

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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Published Research Related To This Trial

Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD.

Monika A Sarkar, Ayako Suzuki, Manal F Abdelmalek...

https://pubmed.ncbi.nlm.nih.gov/33010412

Metabolic dysfunction in polycystic ovary syndrome: Pathogenic role of androgen excess and potential therapeutic strategies.

Miguel A Sanchez-Garrido, Manuel Tena-Sempere

https://pubmed.ncbi.nlm.nih.gov/32244180

Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study.

Alessandra Gambineri, Laura Patton, Antonella Vaccina...

https://pubmed.ncbi.nlm.nih.gov/16868063

Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome.

D Macut, K Tziomalos, I Božić-Antić...

https://pubmed.ncbi.nlm.nih.gov/27076501

Polycystic ovary syndrome, androgen excess, and the risk of nonalcoholic fatty liver disease in women: A longitudinal study based on a United Kingdom primary care database.

Balachandran Kumarendran, Michael W O'Reilly, Konstantinos N Manolopoulos...

https://pubmed.ncbi.nlm.nih.gov/29590099