Pharmacokinetics and Hepatic Safety of EGCG

NCT04177693 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 20000283701R01HD100369-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (8)

• Changes in Total Bilirubin

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

• Changes in ALT/SGPT

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

• Changes in Alkaline Phosphatase

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

• Changes in Estrogen (E2)

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

• Changes in Endometrial Thickness

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

Study Arms (3)

EGCG daily alone.

EXPERIMENTAL

EGCG daily alone. 800mg

Dietary Supplement: Epigallocatechin gallate (EGCG)

EGCG with clomiphene citrate

EXPERIMENTAL

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

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

EGCG with letrozole

EXPERIMENTAL

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

Dietary Supplement: Epigallocatechin gallate (EGCG); Drug: Letrozole

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

EGCG daily alone.; EGCG with clomiphene citrate; EGCG with letrozole

Clomiphene Citrate DRUG

100 mg for 5 days

Also known as: Clomid, Serophene

EGCG with clomiphene citrate

Letrozole DRUG

5 mg for 5 days

Also known as: Femara

EGCG with letrozole

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

epigallocatechin gallate; Clomiphene; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Heping Zhang
• Organization: Yale University

heping.zhang@yale.edu

2037855185

Study Officials

• Esther Eisenberg, MD

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

  STUDY DIRECTOR

• Ayman Al-Hendy, MD,PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Heping Zhang, PhD

  Yale University

  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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Obstetrics, Gynecology and Reproductive Sciences

Model Details: The 36 women will be randomized to one of the following groups: 1. EGCG daily alone. 2. EGCG daily with clomiphene citrate 100mg for 5 days. 3. EGCG daily with letrozole 5mg for 5 days.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: November 24, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-05

Locations

US (1)