Pharmacokinetics and Hepatic Safety of EGCG
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Changes in Epigallocatechin Gallate (EGCG)
研究概览
简要总结
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
详细描述
This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial conducted in women with and without fibroids will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
- •Must use a double-barrier method for contraception
排除标准
- •Subjects using green tea/EGCG within 2 weeks prior to study enrollment
- •Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
- •History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
- •Subject using hormonal contraceptives
- •Subjects who are pregnant or breastfeeding
- •Known hypersensitivity to the study drugs
- •Any chronic disease
研究组 & 干预措施
EGCG daily alone.
EGCG daily alone. 800mg
干预措施: Epigallocatechin gallate (EGCG) (Dietary Supplement)
EGCG with clomiphene citrate
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
干预措施: Epigallocatechin gallate (EGCG) (Dietary Supplement)
EGCG with clomiphene citrate
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
干预措施: Clomiphene Citrate (Drug)
EGCG with letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
干预措施: Epigallocatechin gallate (EGCG) (Dietary Supplement)
EGCG with letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
干预措施: Letrozole (Drug)
结局指标
主要结局
Changes in Epigallocatechin Gallate (EGCG)
时间窗: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.
Changes in Epigallocatechin (EGC)
时间窗: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.
Changes in Epicatechin Gallate(ECG)
时间窗: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.
次要结局
- Changes in ALT/SGPT(Baseline, and Visit 4 (end of study, up to 40 days))
- Changes in Total Bilirubin(Baseline, and Visit 4 (end of study, up to 40 days))
- Changes in Alkaline Phosphatase(Baseline, and Visit 4 (end of study, up to 40 days))
- Changes in Endometrial Thickness(Baseline, and Visit 4 (end of study, up to 40 days))
- Changes in Estrogen (E2)(Baseline, and Visit 4 (end of study, up to 40 days))
- Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group(Baseline, and Visit 4 (end of study, up to 40 days))
- Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group(Baseline, and Visit 4 (end of study, up to 40 days))
- Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.(Baseline, and Visit 4 (end of study, up to 40 days))
研究者
Hugh Taylor
Chair of Obstetrics, Gynecology and Reproductive Sciences
Yale University