16 completed, 7 terminated, 1 active not recruiting. 16 Phase 2, 7 Phase 1, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 9, Terminated 6, Active not recruiting 1 |
| Phase 1 | 7 | Completed 6, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow polyphenon E: new trials by email Literature Review of polyphenon E trials Research Report on polyphenon E
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration - Prostate Carcinoma | Phase 2 | Active not recruiting | ECOG-ACRIN Cancer Research Group | 360 | 2021-10-05 | 2026-09-04 |
| Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment 5% sinecatechins ointment, Placebo, 10% sinecatechins ointment - Sexual Pain Disorders, Postmenopausal Symptoms | Phase 2 | Terminated | GTO Pharmaceutical, LLC | 32 | 2018-08-30 | 2022-07-27 |
| Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer defined green tea catechin extract, placebo, questionnaire administration - Advanced Colorectal Adenomas, Adenocarcinoma of the Colon | Phase 2 | Terminated | Mayo Clinic | 39 | 2012-06-01 | 2017-10-27 |
| Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II Polyphenon E, Placebo - Multiple Sclerosis | Phase 2 | Terminated | Louisiana State University Health Sciences Center in New Orleans | 11 | 2011-07-01 | 2014-03-14 |
| Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals Polyphenon E, Placebo - HIV Infection | Phase 1 | Completed | Baylor College of Medicine | 23 | 2010-12-01 | 2023-05-19 |
| A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ Polyphenon E - Ductal Carcinoma in Situ | Phase 2 | Terminated | University of Chicago | 20 | 2010-05-01 | 2020-04-09 |
| Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage Polyphenon E (Veregen) 15% ointment, Green Tea Beverage with defined catechin content - Genital Warts, Perianal Warts | Phase 4 | Completed | MediGene | 43 | 2010-01-01 | 2010-09-08 |
| Safety of Polyphenon E in Multiple Sclerosis Pilot Study Polyphenon E - Multiple Sclerosis | Phase 1 | Completed | Louisiana State University Health Sciences Center in New Orleans | 10 | 2009-02-01 | 2013-06-27 |
| Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis, Pharmacological Study - Stage I Bladder Cancer, Stage II Bladder Cancer | Phase 2 | Completed | National Cancer Institute (NCI) | 31 | 2008-07-02 | 2017-11-17 |
| Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis Polyphenon E®, Placebo Oral Tablet - Mild to Moderately Active Ulcerative Colitis | Phase 2 | Completed | University of Louisville | 20 | 2008-03-01 | 2017-12-14 |
| Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer Polyphenon E, Tarceva - Non-Small Cell Lung Cancer | Phase 1 | Terminated | Louisiana State University Health Sciences Center Shreveport | 11 | 2008-01-01 | 2015-04-21 |
| Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia Polyphenon E, Placebo - Prostatic Hyperplasia | Phase 2 | Completed | H. Lee Moffitt Cancer Center and Research Institute | 97 | 2007-11-14 | 2019-10-04 |
| Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer placebo, quality-of-life assessment, questionnaire administration - Estrogen Receptor-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer | Phase 1 | Completed | National Cancer Institute (NCI) | 40 | 2007-07-01 | 2014-09-12 |
| Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate defined green tea catechin extract, placebo, immunohistochemistry staining method - Adenocarcinoma of the Prostate, Stage I Prostate Cancer | Phase 1 | Completed | National Cancer Institute (NCI) | 50 | 2007-03-01 | 2014-10-08 |
| Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery defined green tea catechin extract, placebo, immunohistochemistry staining method - Stage I Prostate Cancer, Stage IIA Prostate Cancer | Phase 2 | Terminated | Case Comprehensive Cancer Center | 5 | 2006-10-01 | 2012-03-15 |
| Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus placebo, defined green tea catechin extract - Barrett Esophagus | Phase 1 | Completed | National Cancer Institute (NCI) | 55 | 2005-11-01 | 2014-09-11 |
| Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia placebo, defined green tea catechin extract, laboratory biomarker analysis - Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 1 | Phase 2 | Completed | National Cancer Institute (NCI) | 98 | 2005-09-01 | 2015-05-05 |
| Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia Polyphenon E - Leukemia | Phase 1 / Phase 2 | Completed | Mayo Clinic | 73 | 2005-08-01 | 2013-05-30 |
| Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer green tea catechin extract, fish oil, placebo - Precancerous Condition, Prostate Cancer | Not applicable | Completed | OHSU Knight Cancer Institute | 89 | 2005-07-01 | 2017-04-18 |
| Green Tea Extract and Prostate Cancer Polyphenon E (EGCG) - Prostate Cancer | Phase 2 | Completed | Louisiana State University Health Sciences Center Shreveport | 33 | 2004-05-01 | 2012-08-08 |
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Prostatic Neoplasms (6) · Breast Neoplasms (2) · Multiple Sclerosis (2) · Urinary Bladder Neoplasms (2) · Barrett Esophagus (1) · Carcinoma, Intraductal, Noninfiltrating (1) · Carcinoma, Non-Small-Cell Lung (1) · Colitis (1) · Colitis, Ulcerative (1) · Colonic Neoplasms (1) · Condylomata Acuminata (1) · Dyspareunia (1) · HIV Infections (1) · Inflammatory Bowel Diseases (1) · Leukemia (1)
National Cancer Institute (NCI) (5) · Louisiana State University Health Sciences Center Shreveport (3) · Louisiana State University Health Sciences Center in New Orleans (2) · Mayo Clinic (2) · Baylor College of Medicine (1) · Case Comprehensive Cancer Center (1) · ECOG-ACRIN Cancer Research Group (1) · Frank Meyskens (1) · GTO Pharmaceutical, LLC (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Jonsson Comprehensive Cancer Center (1) · MediGene (1) · OHSU Knight Cancer Institute (1) · Sherry Chow (1) · University of Chicago (1)
United States (23) · Germany (1) · Guam (1) · Puerto Rico (1)
Arie Belldegrun, MD, FACS (1) · Charles Lightdale (1) · Dawn Hershman (1) · Filiz Seeborg, MD, MPH (1) · Francisco Garcia (1) · Frank L. Meyskens, MD, FACP (1) · Frank Sinicrope (1) · Frank Wagner, Md, PD (1) · Frederick Ahmann (1) · Gary Burton, M.D. (1) · Gerald W Dryden, MD, MSPH (1) · Glenn M Mills, MD (1) · Iman Hakim, MD, PhD, MPH (1) · Jackilen Shannon, PhD (1) · Jerry W McLarty, Ph.D. (1)
PMID 26298797, PMID 12903852, PMID 15598753, PMID 19470922, PMID 19542190, PMID 22044694, PMID 22760587, PMID 22827973, PMID 23846486, PMID 24388920, PMID 25873370, PMID 27646578, PMID 27842331, PMID 28053292, PMID 29228755
K23AT004433 (2), N01CN35158 (2), N01CN35159 (2), P30CA023074 (2), K23DK073750 (1), N01CN35153 (1), P30CA013696 (1), P30CA014520 (1), P30CA015083 (1), P30CA016672 (1), P30CA069533 (1), R21AT004673 (1), U01CA101204 (1), UG1CA189828 (1)