Status:
RECRUITING
Bicalutamide Therapy in Young Women With NAFLD and PCOS
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
NAFLD
PCOS
Eligibility:
FEMALE
18-42 years
Phase:
PHASE1
Brief Summary
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. Women are a...
Detailed Description
This is a single center, double-blind, placebo-controlled, randomized, (1:1) parallel group pilot clinical trial of bicalutamide in women with either biopsy-proven or believed NAFLD receiving 6 months...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05979389
Start Date
February 14 2024
End Date
August 1 2028
Last Update
May 8 2025
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143