Pharmacokinetics and Hepatic Safety of EGCG

May 8, 2023 updated by: Hugh Taylor, Yale University
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EGCG daily alone.
EGCG daily alone. 800mg
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
Experimental: EGCG with clomiphene citrate
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
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
Other Names:
  • Clomid
  • Serophene
Experimental: EGCG with letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
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: Letrozole
5 mg for 5 days
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Epigallocatechin Gallate (EGCG)
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
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.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Epigallocatechin (EGC)
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Epicatechin Gallate(ECG)
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.
Baseline, and Visit 4 (end of study, up to 40 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Total Bilirubin
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in total bilirubin between the 3 groups.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in ALT/SGPT
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in alanine aminotransferase /SGPT between the 3 groups.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Alkaline Phosphatase
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Alkaline Phosphatase between the 3 groups.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Estrogen (E2)
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Estrogen (E2) between the 3 groups.
Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Endometrial Thickness
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in endometrial thickness between the 3 groups.
Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group
Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group
Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
Time Frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.
Baseline, and Visit 4 (end of study, up to 40 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Chicago
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Esther Eisenberg, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Principal Investigator: Ayman Al-Hendy, MD,PhD, University of Chicago
  • Study Director: James Segars, MD, Johns Hopkins University
  • Study Director: Hugh Taylor, MD, Yale University
  • Study Director: Frank Gonzales, MD, University of Illinois Chicago
  • Study Director: Heping Zhang, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000028370
  • 1R01HD100369-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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