Bicalutamide Therapy in Young Women With NAFLD and PCOS

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how a treatment called bicalutamide might help young women who have nonalcoholic steatohepatitis (NASH) and polycystic ovary syndrome (PCOS). NASH is a condition where fat builds up in the liver, causing inflammation and possible scarring, and it is becoming a major health concern, especially for women. The study aims to understand how certain hormones, particularly androgens (which are often elevated in women with PCOS), affect liver health and may contribute to worsening liver damage. By learning more about this, researchers hope to develop better treatments for the nearly 5 million young women with these conditions in the U.S.

To participate in this trial, women aged 18 to 40 years who have been diagnosed with PCOS and NASH may be eligible. Key requirements include having specific liver test results that indicate NASH and not having certain health issues like uncontrolled diabetes or recent alcohol abuse. Participants will undergo various assessments and receive the study treatment to see how it impacts their liver health. It’s important to know that this is a research study, so not everyone will receive the same treatment, and participants will be closely monitored throughout the trial.

Gender

FEMALE

Eligibility criteria

• 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 ≥270 decibel/m and TE score \> 7.0 kPA or alanine aminotransferase ≥40 U/L).
• Exclusion Criteria:
• • Uncontrolled diabetes
• • Alcohol consumption \>2 drinks per day for at least 3 consecutive months over the previous 5 years
• • Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause
• • Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH
• • HIV infection
• • Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior 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 3 months within one year prior to baseline