Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT04177693
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Hepatic Safety of EGCG
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Pharmacokinetics and Hepatic Safety of EGCG
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD100369-01 | NIH | None | https://reporter.nih.gov/quic… | View |