Phase 1
Completed N=39
Pharmacokinetics and Hepatic Safety of EGCG
Source: ClinicalTrials.gov NCT04177693 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Changes in Epigallocatechin Gallate (EGCG) — 5.8; 256.3; 86.4 nM — p=0.112
Summary
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Epigallocatechin Gallate (EGCG) |
5.8; 256.3; 86.4 | 0.112 |
| PRIMARY Changes in Epigallocatechin (EGC) |
-58.9; 8.9; 35.4 | 0.613 |
| PRIMARY Changes in Epicatechin Gallate(ECG) |
7.6; 64.1; 60.3 | 0.202 |
| SECONDARY Changes in Total Bilirubin |
0.1; 0; 0 | 0.508 |
| SECONDARY Changes in ALT/SGPT |
1.1; 4.4; -1.0 | 0.237 |
| SECONDARY Changes in Alkaline Phosphatase |
-1.5; -5.6; -6.0 | 0.327 |
| SECONDARY Changes in Estrogen (E2) |
-50.9; -49.4; -50.2 | 0.633 |
| SECONDARY Changes in Endometrial Thickness |
-1.9; 1.4; 0.6 | 0.146 |
| SECONDARY Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group |
-3.2; -2.0 | 0.372 |
| SECONDARY Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group |
-1.5; -3.8 | 0.07 |
| SECONDARY Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group. |
-3.9; -2.1 | 0.24 |
Eligibility Criteria
Inclusion Criteria
- Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
- Must use a double-barrier method for contraception
Exclusion Criteria
- Subjects using green tea/EGCG within 2 weeks prior to study enrollment
- Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
- History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
- Subject using hormonal contraceptives
- Subjects who are pregnant or breastfeeding
- Known hypersensitivity to the study drugs
- Any chronic disease
Data sourced from ClinicalTrials.gov (NCT04177693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.