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Completed

NCT Number: NCT04177693

Pharmacokinetics and Hepatic Safety of EGCG

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

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Clomiphene Citrate

Drug

100 mg for 5 days

Other names: Clomid, Serophene

letrozole

Drug

5 mg for 5 days

Other names: Femara

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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