Bicalutamide treatment for young women with liver disease and PCOS
Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05979389 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-42 with hyperandrogenic PCOS and either biopsy-proven or probable NAFLD.
Not a fit: Patients with uncontrolled diabetes, other chronic liver diseases, or those who are pregnant or perimenopausal may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.