NCT04177693

Pharmacokinetics and Hepatic Safety of EGCG

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
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
DRUG	Letrozole	5 mg for 5 days

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2019-11-26
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study