Pilot Study of Bicalutamide Versus Placebo in Women Aged 18 to 42 With NAFLD and PCOS

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.

Bicalutamide Therapy in Young Women With NAFLD and PCOS