Bicalutamide for NAFLD and PCOS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests bicalutamide, a medication that blocks certain hormones, in women with NAFLD and PCOS. The goal is to see if it can reduce liver damage by stopping harmful hormone effects.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications associated with fatty liver, such as amiodarone, methotrexate, and others, for more than 4 weeks before starting the study. Additionally, you cannot have used androgen receptor antagonists like spironolactone or flutamide for more than 3 months within the past year.
How is the drug Bicalutamide unique for treating NAFLD and PCOS?
Bicalutamide is unique because it is primarily used as an anti-androgen (a substance that blocks male hormones) in prostate cancer treatment, and its use for NAFLD and PCOS is novel, as these conditions are not typically treated with anti-androgens. This approach may offer a new way to address the hormonal imbalances associated with PCOS and its link to NAFLD.12345
Who Is on the Research Team?
Monika Sarkar
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for young women aged 18-40 with PCOS and NAFLD, diagnosed through liver biopsy or specific tests. Participants should not have used certain drugs that affect the liver, have uncontrolled diabetes, severe kidney issues, a history of excessive alcohol use, other chronic liver diseases or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of bicalutamide or placebo once daily for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bicalutamide
Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator