What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Bicalutamide 50 mg, or Placebo. The registry lists allocation as randomized. 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.
They plan to enroll about 50 people at San Francisco. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)
Interventions: Bicalutamide 50 mg, Placebo
Primary outcome (registry wording): Change in liver stiffness on Magnetic Resonance Elastography (MRE)