Bicalutamide Compared With Placebo in Young Women With Fatty Liver and PCOS
Tests bicalutamide against placebo in women with fatty liver disease and polycystic ovary syndrome.
Key facts
- Who runs it
- University of California, San Francisco
- Where
- San Francisco, United StatesSee the site
- Trial code
- Registry title
- Bicalutamide Therapy in Young Women With NAFLD and PCOS
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 50 people, planned
- Started
- 14 Feb 2024
- Expected to end
- Aug 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Bicalutamide 50 mg
- Placebo
- Record updated
- 29 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 42 with PCOS who have high androgen (male hormone) levels and fatty liver inflammation (NASH). It compares bicalutamide 50 mg with placebo.
- Age
- 18 to 42 years
- Sex
- Women only
- Disease stage
- Hyperandrogenic PCOS with NASH shown on liver biopsy, or probable NASH on a liver scan (TE-CAP: CAP score ≥270 decibel/m and TE score > 7.0 kPA) or alanine aminotransferase ≥40 U/L.
- Earlier treatment
- Cannot have used an androgen receptor blocker (spironolactone or flutamide) for more than 3 months within one year before the start. Cannot have taken drugs linked to fatty liver for more than 4 weeks before the start or during the study.
- Biomarker or test result
- CAP score ≥270 decibel/m and TE score > 7.0 kPA on the liver scan, or alanine aminotransferase ≥40 U/L.
Main reasons for not taking part
- Uncontrolled diabetes
- Other chronic liver disease or cirrhosis from any cause
- HIV infection
- Recent, current or planned pregnancy, or current perimenopause
- Kidney problems (glomerular filtration rate <45 ml/min/1.73m or potassium > 5.0 mmol/L)
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Alcohol consumption >2 drinks per day for at least 3 consecutive months over the previous 5 years
- Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH
- 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
- Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3 months within one year prior to baseline
- Uncontrolled diabetes
- Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause
- HIV infection
- Renal impairment (glomerular filtration rate <45 ml/min/1.73m or potassium levels > 5.0 mmol/L)
- Recent, current, or planned upcoming pregnancy or current perimenopausal status
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 42 years old?
Where in United States
- University of California San FranciscoSan Francisco, United StatesContact: Lily CarbullidoTaking people
About the trial
What the trial wants to find out
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 at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process. Such findings will provide the rationale for future efficacy studies evaluating selective androgen receptor (AR) antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity or lipid-specific pathways as part of a precision medicine approach to halt fibrosis progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain at increased risk for early onset and progressive liver disease.
The 2 groups in the trial
- BicalutamideTreatment being tested
50 mg capsule administered orally once daily for 6 months
Treatment: Bicalutamide 50 mg
- PlaceboPlacebo, for comparison
Matching placebo capsule administered orally once daily for 6 months
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)
- Plain-language title
- Bicalutamide Compared With Placebo in Young Women With Fatty Liver and PCOSGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05979389, who can take part
- Record updated
- 29 May 2026