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

NCT01311869 | Terminated Phase 2 DMC

• 1 other identifier: Green Tea Study
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leiomyoma

Outcome Measures

Primary Outcomes (1)

• fibroid size

  6 months

Secondary Outcomes (1)

• Quality of life

  Every month for 6 months

Study Arms (2)

EGCG ( Green Tea extract)

ACTIVE COMPARATOR

40 subjects will receive 800 mg EGCG orally per day for 6 months versus 40 subjects will receive Brown Rice pill for 6 months

Dietary Supplement: EGCG ( Green Tea extract); Dietary Supplement: Brown rice pills

Brown Rice pills

PLACEBO COMPARATOR

40 subjects will receive 800 mg brown rice pills orally per day for 6 months versus 40 subjects will receive EGCG capsule for 6 months

Dietary Supplement: EGCG ( Green Tea extract); Dietary Supplement: Brown rice pills

Interventions

EGCG ( Green Tea extract) DIETARY_SUPPLEMENT

A randomized double-blind placebo-controlled clinical trial will be conducted with 80 women of reproductive age,the 80 women will be allocated into two groups, 40 each. Each group will be given one of two interventions: The first is 2 capsules of (EGCG which is green tea extract, taken orally with food on daily basis for 6 months, each capsule contain 326.25 mg decaffeinated EGCG,The second group will receive matched (color, taste and texture) placebo for a period of 6 months.

Brown Rice pills; EGCG ( Green Tea extract)

Brown rice pills DIETARY_SUPPLEMENT

40 subjects will receive 800 mg EGCG orally daily for 6 months, the other 40 subject will receive brown rice pills for the same duration.

Brown Rice pills; EGCG ( Green Tea extract)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female; Age: 18Y or older.
• Pre-menopausal.
• FSH level is less than 10 mIU/L.
• Have at least moderate uterine fibroid-related symptoms (score of 24 or higher according to UFS-QOL questionnaire.
• Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is ≥ 2.5cm in diameter.
• Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy.
• Agree to report any pregnancy to the research staff immediately.
• Willing and able to give informed consent.
• Willing and able to comply with study requirements.
• Liver function (ALT, AST, Prothrombin time and concentration)to be≤ 1.5 times the upper limit of normal

You may not qualify if:

• Current or planned pregnancy during the study period.
• Menopausal, as indicated by elevated follicle stimulating hormone (FSH) serum level.
• Currently breast-feeding.
• Untreated abnormal pap smear.
• Presence of conditions other than fibroids contributing to pelvic pain and/or bleeding;
• Hemoglobin \< 8.0 mg/dl.
• Presence of adnexal masses or tenderness indicating the need for further evaluation or surgery.
• Grade III or IV hydronephrosis by ultrasound.
• Mental health disorder.
• Active substance abuse or dependence.
• Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, Herbal or botanical supplements with possible hormonal or EGCG effects. Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera,
• Current or planned use during the study of any of the following medications/or products: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampin, St John's Wort, phenytoin, phenobarbital, or carbamazepine.

Sponsors & Collaborators

• Meharry Medical College: lead

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Related Publications (1)

• Johnson JJ, Siblini H, Al-Hendy A, Segars JH, Gonzalez F, Taylor HS, Singh B, Carson SA, Christman GM, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clin Transl Sci. 2025 Mar;18(3):e70189. doi: 10.1111/cts.70189.

  PMID: 40077973 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

epigallocatechin gallate; Tea

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ayman Al-Hendy, MD, PhD

  Meharry Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 10, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

US (1)