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NCT05364008 · ClinicalTrials.gov registry record · Phase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
A Phase 3 study of Leiomyoma, Uterine, sponsored by Yale University.
- Active
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
- 4
- Study locations
NCT05364008: Active Phase 3 study of Leiomyoma, Uterine, sponsored by Yale University.
NCT05364008 is a Phase 3 study of Leiomyoma, Uterine that is active but no longer recruiting, run by Yale University. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05364008, a Phase 3 study of Leiomyoma, Uterine, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment. The population will consist of 50 women desirous of conceiving, ages ≥18 to ≤40 years (at time of consent), and known to have class 2-6 fibroids, according to the FIGO staging system.
Primary Outcome
The number of women achieving live birth.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Green Tea Extract
Study Locations (4)
Illinois
- University of Illinois at Chicago College of Medicine - Chicago
- University of Chicago, Department of Obstetrics and Gynecology - Chicago
Connecticut
- Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences - New Haven
Maryland
- Johns Hopkins, Division of Reproductive Science and Women's Health Research - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What the registry record for NCT05364008 still lists
NCT05364008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Leiomyoma, Uterine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05364008 reports a single indexed study location in Illinois, Connecticut, Maryland.
Frequently Asked Questions
What is clinical trial NCT05364008 about?
NCT05364008 is a clinical study titled "FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea". The objective of this study is to determine the effect of low caffeine green tea extract containing 45% epigallocatechin gallate (EGCG) on fibroids and subsequent pregnancy and live births in women seeking fertility treatment. The population will consist of 50 women desirous of conceiving, ages ≥18...
What is the current status of trial NCT05364008?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2023-01-05. Estimated completion is 2026-09-30.
What conditions does trial NCT05364008 study?
This clinical trial studies the following conditions: Leiomyoma, Uterine.
What interventions are being tested in trial NCT05364008?
The interventions under investigation include: Placebo (OTHER), Green Tea Extract (DRUG).
Who is sponsoring clinical trial NCT05364008?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05364008 being conducted?
This trial has 4 study locations across Connecticut, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05364008's enrollment target sits among peer trials
33 1908th of 2000 higher than 92 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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