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Pharmacokinetics and Hepatic Safety of EGCG

Uterine Fibroids Clinical Trial

Official title:
Pharmacokinetics and Hepatic Safety of EGCG

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04177693
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Phase 1
Start date November 24, 2020
Completion date January 31, 2022
View Details
See also
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