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Pharmacokinetics and Hepatic Safety of EGCG

Primary Purpose

Uterine Fibroids

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Epigallocatechin gallate (EGCG)

Clomiphene Citrate

Letrozole

About this trial

This is an interventional other trial for Uterine Fibroids

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
Must use a double-barrier method for contraception

Exclusion Criteria:

Subjects using green tea/EGCG within 2 weeks prior to study enrollment
Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
Subject using hormonal contraceptives
Subjects who are pregnant or breastfeeding
Known hypersensitivity to the study drugs
Any chronic disease

Sites / Locations

Johns Hopkins Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

EGCG daily alone.

EGCG with clomiphene citrate

EGCG with letrozole

Arm Description

EGCG daily alone. 800mg

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

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

Outcomes

Primary Outcome Measures

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.

Changes in Epigallocatechin (EGC)

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.

Changes in Epicatechin Gallate(ECG)

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.

Secondary Outcome Measures

Changes in Total Bilirubin

Changes in total bilirubin between the 3 groups.

Changes in ALT/SGPT

Changes in alanine aminotransferase /SGPT between the 3 groups.

Changes in Alkaline Phosphatase

Changes in Alkaline Phosphatase between the 3 groups.

Changes in Estrogen (E2)

Changes in Estrogen (E2) between the 3 groups.

Changes in Endometrial Thickness

Changes in endometrial thickness between the 3 groups.

Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group

Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group

Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group

Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group

Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.

Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.

Full Information

NCT ID

NCT04177693

First Posted

November 20, 2019

Last Updated

May 8, 2023

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

1. Study Identification

Unique Protocol Identification Number

NCT04177693

Brief Title

Pharmacokinetics and Hepatic Safety of EGCG

Official Title

Pharmacokinetics and Hepatic Safety of EGCG

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 24, 2020 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

The 36 women will be randomized to one of the following groups: EGCG daily alone. EGCG daily with clomiphene citrate 100mg for 5 days. EGCG daily with letrozole 5mg for 5 days.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EGCG daily alone.

Arm Type

Experimental

Arm Description

EGCG daily alone. 800mg

Arm Title

EGCG with clomiphene citrate

Arm Type

Experimental

Arm Description

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

Arm Title

EGCG with letrozole

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Epigallocatechin gallate (EGCG)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clomiphene Citrate

Other Intervention Name(s)

Clomid, Serophene

Intervention Description

100 mg for 5 days

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

Femara

Intervention Description

5 mg for 5 days

Primary Outcome Measure Information:

Title

Changes in Epigallocatechin Gallate (EGCG)

Description

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.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in Epigallocatechin (EGC)

Description

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.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in Epicatechin Gallate(ECG)

Description

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.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Secondary Outcome Measure Information:

Title

Changes in Total Bilirubin

Description

Changes in total bilirubin between the 3 groups.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in ALT/SGPT

Description

Changes in alanine aminotransferase /SGPT between the 3 groups.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in Alkaline Phosphatase

Description

Changes in Alkaline Phosphatase between the 3 groups.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in Estrogen (E2)

Description

Changes in Estrogen (E2) between the 3 groups.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Changes in Endometrial Thickness

Description

Changes in endometrial thickness between the 3 groups.

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group

Description

Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group

Description

Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group

Time Frame

Baseline, and Visit 4 (end of study, up to 40 days)

Title

Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.

Description

Change in serum folate levels 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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Esther Eisenberg, MD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ayman Al-Hendy, MD,PhD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heping Zhang, PhD

Organizational Affiliation

Yale University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

James Segars, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hugh Taylor, MD

Organizational Affiliation

Yale University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Frank Gonzales, MD

Organizational Affiliation

University of Illinois Chicago

Official's Role

Study Director

Facility Information:

Facility Name

Johns Hopkins Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Hepatic Safety of EGCG

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