Clinical trial · Interventional
Pharmacokinetics and Hepatic Safety of EGCG
NCT04177693CI-TRIAL-00066905completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene Citrate | Drug | — | UNRESOLVED |
| Epigallocatechin gallate (EGCG) | Dietary Supplement | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EGCG daily alone.
- description
- EGCG daily alone. 800mg
- interventionNames
- Dietary Supplement: Epigallocatechin gallate (EGCG)
- type
- EXPERIMENTAL
- label
- EGCG with clomiphene citrate
- description
- EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
- interventionNames
- Dietary Supplement: Epigallocatechin gallate (EGCG)
- Drug: Clomiphene Citrate
- type
- EXPERIMENTAL
- label
- EGCG with letrozole
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJohnson JJ, Siblini H, Al-Hendy A, Segars JH, Gonzalez F, Taylor HS, Singh B, Carson SA, Christman GM, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clin Transl Sci. 2025 Mar;18(3):e70189. doi: 10.1111/cts.70189. PMID 40077973