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Bicalutamide for NAFLD and PCOS in Young Women

This study is looking at how bicalutamide 50 mg, a medication, might help young women with Non-Alcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS). NAFLD is a condition where too much fat builds up in the liver, and it can lead to serious liver problems. Researchers believe that sex hormones might play a role in NAFLD, especially in women with PCOS. This study will compare bicalutamide to a placebo (an inactive pill that looks the same) over 6 months. They want to see if bicalutamide can improve liver stiffness, which is a sign of liver damage, measured by Magnetic Resonance Elastography (MRE). They are looking for 50 women, aged 18 to 42, who have PCOS with high androgen levels and either confirmed or probable NAFLD. The study status is currently unclear.

Study design
This is a single-center, double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you're receiving bicalutamide or the placebo. About 50 women will participate, randomly assigned to one of the two groups.
What's involved
You would take bicalutamide or placebo once daily for 6 months. You would have in-person evaluations at months 1, 2, 3, 4, 5, and 6.
Compensation
Not stated in the trial record.
Follow-up
There will be a telephone follow-up visit within 1 month after your treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05979389

Bicalutamide Therapy in Young Women With NAFLD and PCOS

Recruiting
PHASE1Ages 18–42Interventional
University of California, San Francisco
~50 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Bicalutamide 50 mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in liver stiffness on Magnetic Resonance Elastography (MRE)
Measured over Baseline and 6 months

Conditions

NAFLD
PCOS

Explore related trials

Nonalcoholic SteatohepatitisPolycystic Ovary Syndrome

NCT05979389

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Monika A Sarkar, MD, MAS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Lily Carbullido
[email protected]
(415)-502-3725
Email the study team

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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

What this trial measures

  • Change in liver stiffness on Magnetic Resonance Elastography (MRE)Baseline and 6 months

    The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)