Pharmacokinetics and Hepatic Safety of EGCG

Uterine Fibroids Clinical Trial

Official title:

Pharmacokinetics and Hepatic Safety of EGCG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177693
• Other study ID #: 2000028370
• Secondary ID: 1R01HD100369-01
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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
• Letrozole
5 mg for 5 days

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Changes in Total Bilirubin	Changes in total bilirubin between the 3 groups.	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	Changes in ALT/SGPT	Changes in alanine aminotransferase /SGPT between the 3 groups.	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	Changes in Alkaline Phosphatase	Changes in Alkaline Phosphatase between the 3 groups.	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	Changes in Estrogen (E2)	Changes in Estrogen (E2) between the 3 groups.	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	Changes in Endometrial Thickness	Changes in endometrial thickness between the 3 groups.	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	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	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	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	Baseline, and Visit 4 (end of study, up to 40 days)
Secondary	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.	Baseline, and Visit 4 (end of study, up to 40 days)