Pharmacokinetics and Hepatic Safety of EGCG

Summary

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

Conditions

• Uterine Fibroids

Interventions

DIETARY_SUPPLEMENT

Epigallocatechin gallate (EGCG)

800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

DRUG

Clomiphene Citrate

100 mg for 5 days

DRUG

Letrozole

5 mg for 5 days

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Illinois at Chicago

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Ayman Al-Hendy, MD,PhD · University of Chicago

• Heping Zhang, PhD · Yale University

• James Segars, MD · Johns Hopkins University

• Hugh Taylor, MD · Yale University

• Frank Gonzales, MD · University of Illinois Chicago

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-24

Primary Completion

2022-01-31

Completion

2022-01-31

FDA Drug

Yes

Countries

• United States

Study Locations