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Pharmacokinetics and Hepatic Safety of EGCG | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT04177693

Pharmacokinetics and Hepatic Safety of EGCG

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

Lead sponsor: Yale University•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Illinois at Chicago
Johns Hopkins University
University of Chicago

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.

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 5, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment39

Start dateNov 2020

Last updatedJun 5, 2023

Condition

Uterine Fibroids

Locations shown

Johns Hopkins Medicine

Baltimore, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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