Estrogen Administration for the Treatment of NASH in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Liver fat
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation, and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with a particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fat and fibrosis in post-menopausal women with NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women 45-70 years old
- •NASH by biopsy or NAFLD by imaging within 6 months of screen
- •Hepatitis C antibody and hepatitis B surface antigen negative
- •Negative mammogram within 1 year
排除标准
- •Heavy alcohol use
- •Use of NASH pharmacotherapies within 12 months of study entry
- •Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
- •Participation in NASH clinical trial within 6 months of study entry
- •Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
- •Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
- •Contraindication to liver biopsy including INR > 1.5, platelets < 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes
- •Hgb < 10.0 g/dL or glomerular filtration rate < 60 mL/min
- •Contraindications to estrogen therapy
- •Any vaginal bleeding, including spotting, within the last year
- •Active malignancy
- •Severe chronic illness
- •Use of estrogen or progesterone within a year of baseline visit
- •Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
研究组 & 干预措施
Placebo
Placebo patch (containing no estradiol) Women with an intact uterus will also receive vaginal placebo capsules (containing no progesterone)
干预措施: Placebo (Drug)
Estradiol
Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic).
Women with an intact uterus will also receive progesterone (100 mg) in the form of a vaginal tablet (Endometrin, Ferring Pharmaceuticals, Inc.) inserted daily for endometrial protection
干预措施: Estradiol patch (Drug)
结局指标
主要结局
Liver fat
时间窗: 12 months
Reduction in amount of fat in the liver
Hepatic fat
时间窗: 12 months
Change in percentage of hepatic fat
次要结局
- Hepatic fibrosis(12 months)
- NAFLD activity score(12 months)
- Whole liver transcriptome profile(12 months)
- Intrahepatic immune cell profiles(12 months)
- Non-alcoholic fatty liver disease activity score(12 months)
研究者
Karen Klahr Miller, MD
Chief, Neuroendocrine Unit, Massachusetts General Hospital
Massachusetts General Hospital