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Hormone Therapy
Bicalutamide for NAFLD and PCOS
Phase 1
Recruiting
Led By Monika A Sarkar, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
Study Summary
This trial will study the risk of NASH in women, looking at androgen hormones and lipid metabolism. It may provide insight to help protect the 15 million US women with NASH from early onset liver disease. #NASH #women #liverdisease
Who is the study for?
This trial is for young women aged 18-40 with PCOS and NAFLD, diagnosed through liver biopsy or specific tests. Participants should not have used certain drugs that affect the liver, have uncontrolled diabetes, severe kidney issues, a history of excessive alcohol use, other chronic liver diseases or be pregnant.Check my eligibility
What is being tested?
The study is testing Bicalutamide's effectiveness in treating fat-related liver inflammation in women with PCOS. It compares Bicalutamide (50 mg) against a placebo to see if it can improve NASH by targeting androgen receptors.See study design
What are the potential side effects?
While the side effects are not detailed here, Bicalutamide commonly includes breast tenderness or enlargement, hot flashes, itching skin or rash and gastrointestinal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in liver stiffness on Magnetic Resonance Elastography (MRE)
Secondary outcome measures
Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))
Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)
+1 moreSide effects data
From 2013 Phase 3 trial • 3040 Patients • NCT0000265170%
Hot flashes
52%
Fatigue/malaise/lethargy
42%
Erectile impotence
36%
Libido loss
33%
Sweating
33%
Bone pain
25%
Gynecomastia
19%
Insomnia
19%
Urinary frequency/urgency
19%
Pain-other
15%
Depression
15%
Creatinine increase
15%
Sensory neuropathy
15%
Dyspnea
13%
Diarrhea without colostomy
13%
Arthralgia
12%
Anemia
12%
Hyperglycemia
11%
Rash/desquamation
11%
Constipation/bowel obstruction
10%
Weakness (motor neuropathy)
8%
Weight gain
8%
Alkaline phosphatase increase
7%
Cough
7%
Nausea
7%
SGOT (AST) increase
6%
Anxiety/agitation
6%
Myalgia
6%
Dizziness/light headedness
5%
Hypertension
1%
Cardiac ischemia/infarction
1%
Flu-like symptoms-other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Continuous Hormonal Therapy
Intermittent Hormonal Therapy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BicalutamideExperimental Treatment1 Intervention
50 mg capsule administered orally once daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsule administered orally once daily for 6 months
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,525 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
4,082 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,542 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,922 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Monika A Sarkar, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.My kidney function is impaired or my potassium levels are high.I am a woman aged 18-40 with PCOS and high male hormone levels.I have a chronic liver condition or cirrhosis.I have been diagnosed with NASH through a liver biopsy or specific liver tests.I have had or plan to have weight loss surgery within 5 years of my NASH diagnosis.My diabetes is not under control.I haven't taken drugs linked to fatty liver for more than 4 weeks.I have consumed more than 2 drinks daily for at least 3 months in the last 5 years.I have used medications like spironolactone for more than 3 months in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Bicalutamide
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Bicalutamide been granted authorization by the FDA?
"Despite limited clinical evidence of safety and efficacy, Bicalutamide was given a score of 1 on Power's scale."
Answered by AI
Who has the opportunity to participate in this research endeavor?
"To partake in this clinical trial, enrollees must have non-alcoholic fatty liver disease and fall within the 18 to 40 year old age bracket. As of now, roughly 50 individuals are required for the study."
Answered by AI
Does this research protocol accept geriatric participants?
"This medical trial is only open to participants aged 18-40, in line with the inclusion criteria."
Answered by AI
Are recruitment efforts still underway for this research project?
"According to the information on clinicaltrials.gov, this specific trial is no longer recruiting participants. It was posted in August 1st 2023 and last updated a few days later; however, there are over two hundred other trials now searching for patients."
Answered by AI
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