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NCT01311869 · ClinicalTrials.gov registry record · Phase 2

Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids

A Phase 2 study, sponsored by Meharry Medical College.

Terminated
Registry status
Phase 2
Development phase
43
Enrollment target

NCT01311869 is a Phase 2 study that was terminated before completion, run by Meharry Medical College. The registered enrollment target is 43 participants.

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The verdict

NCT01311869, a Phase 2 study, was terminated before completion, sponsored by Meharry Medical College.

TERMINATED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study Summary

Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the uterus). African American women are 3-4 times more likely to have uterine fibroids. Currently there is no effective long-term medical treatment for fibroids. Hormones have been used for short-term therapy, but they are not used long-term because of the risk of side effects. When women stop receiving the hormone therapy often fibroids return. Surgery is the common treatment for women who are suffering from abnormal symptoms caused by fibroids. Hysterectomy is an effective treatment, however women cannot have children after removal of the uterus. Epigallocatechin Gallate (EGCG) is one of the main natural chemicals found in green tea.. Research the investigators have done in the laboratory and in animals leads them to believe EGCG may decrease the growth of fibroids. This study is intended to determine whether EGCG will cause fibroid tumors to shrink and reduce fibroid related symptoms such as abnormal vaginal bleeding and pelvic discomfort.

Interventions

  • DIETARY_SUPPLEMENT EGCG ( Green Tea extract)
  • DIETARY_SUPPLEMENT Brown rice pills

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2010-12
Est. Completion 2011-09
Phase Phase 2

Sponsor

Meharry Medical College

10 total trials

What the Registry Record Tells You About NCT01311869

The ClinicalTrials.gov registry entry for NCT01311869 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meharry Medical College, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which EGCG ( Green Tea extract) is the first listed.

NCT01311869 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01311869 about?

NCT01311869 is a clinical study titled "Green Tea Extract: a Non-Surgical Alternative for Treatment of Uterine Fibroids". Uterine Leiomyomata, also known as uterine fibroids, are non-cancer tumors found in the wall of the uterus or womb. Uterine fibroids are the common cause of surgery (removal of the uterus). African American women are 3-4 times more likely to have uterine fibroids. Currently there is no effective lon...

What is the current status of trial NCT01311869?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2010-12. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01311869?

The interventions under investigation include: EGCG ( Green Tea extract) (DIETARY_SUPPLEMENT), Brown rice pills (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01311869?

This trial is sponsored by Meharry Medical College, which has 10 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.