drugset / Trial / NCT04177693
Pharmacokinetics and Hepatic Safety of EGCG
Phase 1
Completed
39 enrolled
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabJohns Hopkins University · collabUniversity of Chicago · collabUniversity of Illinois at Chicago · collab
RandomizedParallel-groupOpen-labelOther
Summary
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
Timeline
- Start
- 2020-11-24
- Primary completion
- 2022-01-31
- Completion
- 2022-01-31
Outcome
Missed primary endpoint
registry analysis (superiority test); EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole; p = 0.112; Kruskal-Wallis NCT04177693 ↗
registry analysis (superiority test); EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole; p = 0.613; Kruskal-Wallis NCT04177693 ↗
registry analysis (superiority test); EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole; p = 0.202; Kruskal-Wallis NCT04177693 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clomiphene Citrate | Other / unclassified | 100 mg | — |
| Subject | Epigallocatechin gallate | Small molecule | 800 mg | Oral |
| Subject | Letrozole | Other / unclassified | 5 mg | — |