Bicalutamide Therapy in Young Women With NAFLD and PCOS

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05979389
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • NAFLD
  • PCOS

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Bicalutamide 50 mg — DRUG
    Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg
  • Placebo — DRUG
    Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.

Study Details

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.

Key Dates

Start date
Feb 14, 2024
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Bicalutamide
    50 mg capsule administered orally once daily for 6 months
  • Placebo Comparator: Placebo
    Matching placebo capsule administered orally once daily for 6 months

Primary Outcome Measure

Change in liver stiffness on Magnetic Resonance Elastography (MRE) [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Lily Carbullido
[email protected]
415-502-3725
Monika Sarkar, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CA

Related Studies