Pharmacokinetics and Hepatic Safety of EGCG

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Johns Hopkins University; University of Illinois at Chicago
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Epigallocatechin gallate; Letrozole; Sodium Citrate; Zuclomiphene

Criteria

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