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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: Clinical Trial Phase 2 study, sponsored by Meharry Medical College.
NCT01311869 is a Phase 2 study that was terminated before completion, run by Meharry Medical College. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT01311869 stopped before completion
NCT01311869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which EGCG ( Green Tea extract) is the first listed.
NCT01311869 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01311869's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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