CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 39 enrolled
Drug / intervention
Clomiphene Citrate +2 moredrug
Likely dose
Clomiphene Citrate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04177693
NCT04177693Phase 1Completed
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Pharmacokinetics and Hepatic Safety of EGCG

Yale University·interventional·Posted Nov 26, 2019·Updated Jun 5, 2023

In Brief

A Phase 1 clinical trial evaluating Epigallocatechin gallate (EGCG), Clomiphene Citrate, and 1 other intervention for Uterine Fibroids. Completed, enrolled 39 participants across 1 site.

Detailed Summary

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois at Chicago, Johns Hopkins University, University of Chicago

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 26, 2019
Enrollment StartNov 24, 2020
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.6 years ago

Interventions

Epigallocatechin gallate (EGCG)dietary

800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

Clomiphene Citratedrug

100 mg for 5 days

Letrozoledrug

5 mg for 5 days