Pharmacokinetics and Hepatic Safety of EGCG

Yale University39 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Uterine Fibroids

Interventions

Epigallocatechin gallate (EGCG)DIETARY_SUPPLEMENT

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

Clomiphene CitrateDRUG

100 mg for 5 days

LetrozoleDRUG

5 mg for 5 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids 2. Must use a double-barrier method for contraception Exclusion Criteria: 1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment 2. Known liver disease (defined as AST or ALT\>2 times normal, or total bilirubin \>2.5 mg/dL). 3. History of alcohol abuse (defined as \>14 drinks/week) or binge drinking of ≥ 6 drinks at one time). 4. Subject using hormonal contraceptives 5. Subjects who are pregnant or breastfeeding 6. Known hypersensitivity to the study drugs 7. Any chronic disease

Locations (1)

Johns Hopkins Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Changes in Epigallocatechin Gallate (EGCG)

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.