Bicalutamide Therapy in Young Women With NAFLD and PCOS

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by University of California, San Francisco
Sponsor
University of California, San Francisco
Information Provided by (Responsible Party)
University of California, San Francisco
Clinicaltrials.gov Identifier
NCT05979389
Other Study ID Numbers:
23-39274
First Submitted
July 27, 2023
First Posted
August 6, 2023
Last Update Posted
April 14, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This is a single center, double-blind, placebo-controlled, randomized, (1:1) parallel group pilot clinical trial of bicalutamide in women with either biopsy-proven or believed NAFLD receiving 6 months of bicalutamide or placebo. 50 women are targeted for enrollment. Each participant will be administered a single dose of bicalutamide or placebo once daily for a total of 6 months. In person evaluations will take place at Month 1, 2, 3, 4, 5, and 6. There will be a telephone follow up visit within 1 month of end of treatment. This is a pilot clinical trial that is largely feasibility focused. Study outcomes will include:

* Change in liver stiffness on Magnetic Resonance Elastography (MRE)

* Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)

* Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)

* Change in NASH histology as assessed by the continuous NAFLD activity score (NAS), which measures different components of NASH on liver biopsy.

* Biochemical endpoints: serum lipids \& HOMA-IR

* Feasibility outcomes including Rates (and reasons) for the following: a) % women that decline/women contacted for study inclusion (i.e. concern regarding randomization to placebo) b) % women enrolled/women screened (i.e. exclusion criteria too narrow), c) study dropout (i.e. medication side effects, too frequent study visits, and/or phlebotomy)

Condition or DiseaseIntervention/Treatment
NAFLDPCOS
Drug: Bicalutamide 50 mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment50 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeOther
Official TitlePilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)
Study Start DateFebruary 13, 2024
Actual Primary Completion Date2yrs 3mos from now
Actual Study Completion Date2yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Bicalutamide
50 mg capsule administered orally once daily for 6 months
Drug: Bicalutamide 50 mg
Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg
Placebo
Matching placebo capsule administered orally once daily for 6 months
Drug: Placebo
Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.

Outcome Measures

Primary Outcome Measures
  1. Change in liver stiffness on Magnetic Resonance Elastography (MRE)
    The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)
Secondary Outcome Measures
  1. Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
    The investigators will assess for percent change in fat fraction by MRI-PDFF
  2. Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)
    The investigators will assess for percent change in VAT as quantified by MRI
  3. Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))
    The investigators will assess change in continuous measures of HOMA-IR as insulin resistance is known to contribute to NASH progression
  4. Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)
    The investigators will assess for change in this histologic scoring system of NASH as a continuous measure among women willing to undergo end of treatment biopsy (not required).

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
Women aged 18-42 years with hyperandrogenic PCOS
NASH identified on liver biopsy or probable NASH on transient elastography- controlled attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel/m and TE score \> 7.0 kPA or alanine aminotransferase ≥40 U/L).
Exclusion Criteria
Uncontrolled diabetes
Alcohol consumption \>2 drinks per day for at least 3 consecutive months over the previous 5 years
Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause
Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH
HIV infection
Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or during study
Recent, current, or planned upcoming pregnancy or current perimenopausal status
Renal impairment (glomerular filtration rate \<45 ml/min/1.73m or potassium levels \> 5.0 mmol/L)
Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3 months within one year prior to baseline

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Francisco
Locations
University of California San Francisco | San Francisco California, United States, 94143
Investigators
Principal Investigator: Monika A Sarkar, MD, MAS, University of California, San Francisco