Bicalutamide Therapy in Young Women With NAFLD and PCOS

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)