Phase
Condition
Liver Disease
Treatment
Bicalutamide 50 mg
Placebo
Clinical Study ID
Ages 18-42 Female
Study Summary
Eligibility Criteria
Inclusion
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 ≥270decibel/m and TE score > 7.0 kPA or alanine aminotransferase ≥40 U/L).
Exclusion
Exclusion Criteria:
Uncontrolled diabetes
Alcohol consumption >2 drinks per day for at least 3 consecutive months over theprevious 5 years
Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmunehepatitis) or cirrhosis from any cause
Recent or planned upcoming weight reduction surgery within five years of diagnosisof biopsy-confirmed NASH
HIV infection
Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemicglucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeksprior 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 3months within one year prior to baseline
Study Design
Study Description
Connect with a study center
University of California San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
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