Spots Global Cancer Trial Database for Pharmacokinetics and Hepatic Safety of EGCG
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Trial Identification
Brief Title: Pharmacokinetics and Hepatic Safety of EGCG
Official Title: Pharmacokinetics and Hepatic Safety of EGCG
Study ID: NCT04177693
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Johns Hopkins Medicine, Baltimore, Maryland, United States
Contact Details
Name: Esther Eisenberg, MD
Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Role: STUDY_DIRECTOR
Name: Ayman Al-Hendy, MD,PhD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Name: Heping Zhang, PhD
Affiliation: Yale University
Role: STUDY_DIRECTOR
Name: James Segars, MD
Affiliation: Johns Hopkins University
Role: STUDY_DIRECTOR
Name: Hugh Taylor, MD
Affiliation: Yale University
Role: STUDY_DIRECTOR
Name: Frank Gonzales, MD
Affiliation: University of Illinois Chicago
Role: STUDY_DIRECTOR
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