Pharmacokinetics and Hepatic Safety of EGCG

Completed · Phase 1

Conditions studied: Uterine Fibroids

In brief

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

Key facts

Study ID

NCT04177693

Run by

Yale University

People needed

39

Starts

2020-11-24

Expected to finish

2022-01-31

Last updated by the study team

2023-06-05

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
• Must use a double-barrier method for contraception

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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