RECRUITING

Bicalutamide Therapy in Young Women With NAFLD and PCOS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)

Quick Facts

Study Start:2024-02-14

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05979389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Women aged 18-40 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).	* 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

Inclusion Criteria

Exclusion Criteria

* Women aged 18-40 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).

* 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

Contacts and Locations

Study Contact

Elle K Oberweis-Manion

CONTACT

(415)-502-3725

elle.oberweismanion@ucsf.edu

Principal Investigator

Monika A Sarkar, MD, MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-14

Study Completion Date2028-08

Study Record Updates

Study Start Date2024-02-14

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

NAFLD
PCOS