Bicalutamide treatment for young women with liver disease and PCOS
Official title: Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)
Run by University of California, San Francisco · NCT05979389 · Data updated 2026-11-12
This study is testing if a medication called bicalutamide can help young women with liver disease and PCOS feel better and improve their liver health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 42 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | February 14, 2024 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT05979389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-42 with hyperandrogenic PCOS and either biopsy-proven or probable NAFLD.
✕Probably not a fit
Patients with uncontrolled diabetes, other chronic liver diseases, or those who are pregnant or perimenopausal may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot clinical trial investigates the effects of bicalutamide, an androgen receptor antagonist, on young women aged 18-42 with nonalcoholic fatty liver disease (NAFLD) and polycystic ovary syndrome (PCOS). The study aims to understand the role of androgens in liver injury and the progression of NAFLD in this population. Participants will receive either bicalutamide or a placebo for six months, with evaluations conducted at regular intervals to assess changes in liver stiffness, hepatic fat content, visceral fat volume, and other biochemical markers. The trial will also evaluate feasibility metrics related to participant enrollment and retention.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for young women suffering from NAFLD and PCOS, potentially halting disease progression.
How similar studies have gone: While this approach is novel in targeting androgen receptors for NAFLD in women with PCOS, similar studies have shown promise in related areas of research.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Monika A Sarkar, MD, MAS — University of California, San Francisco
- Study coordinator: Lily Carbullido
- Email: myliverhealth@ucsf.edu
- Phone: (415)-502-3725
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.