Clinical trial NCT04177693: Pharmacokinetics and Hepatic Safety of EGCG
Official title: Pharmacokinetics and Hepatic Safety of EGCG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Fibroids
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Illinois at Chicago
name: Johns Hopkins University
name: University of Chicago
First posted: 2019-11-26
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 36 women will be randomized to one of the following groups:

1. EGCG daily alone.
2. EGCG daily with clomiphene citrate 100mg for 5 days.
3. EGCG daily with letrozole 5mg for 5 days.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Changes in Epigallocatechin Gallate (EGCG)
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in Epigallocatechin (EGC)
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in Epicatechin Gallate(ECG)
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
Secondary outcomes:
measure: Changes in Total Bilirubin
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in ALT/SGPT
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in Alkaline Phosphatase
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in Estrogen (E2)
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Changes in Endometrial Thickness
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
measure: Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
timeFrame: Baseline, and Visit 4 (end of study, up to 40 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Esther Eisenberg, MD
role: STUDY_DIRECTOR
affiliation: University of Chicago
name: Ayman Al-Hendy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Heping Zhang, PhD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: James Segars, MD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Hugh Taylor, MD
role: STUDY_DIRECTOR
affiliation: University of Illinois Chicago
name: Frank Gonzales, MD
role: STUDY_DIRECTOR
References: