Pharmacokinetics and Hepatic Safety of EGCG

Yale University

Status and phase: Completed; Phase 1

Conditions: Uterine Fibroids

Treatments: Drug: Letrozole; Drug: Clomiphene Citrate; Dietary Supplement: Epigallocatechin gallate (EGCG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04177693

2000028370

1R01HD100369-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

EGCG daily alone.

Experimental group

Description:

EGCG daily alone. 800mg

Treatment:

Dietary Supplement: Epigallocatechin gallate (EGCG)

EGCG with clomiphene citrate

Experimental group

Description:

EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.

Treatment:

Dietary Supplement: Epigallocatechin gallate (EGCG)

Drug: Clomiphene Citrate

EGCG with letrozole

Experimental group

Description:

EGCG 800mg daily with letrozole 5mg for 5 days.

Treatment:

Dietary Supplement: Epigallocatechin gallate (EGCG)

Drug: Letrozole