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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Leiomyoma

In brief

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.

Key facts

Study ID

NCT01311869

Run by

Meharry Medical College

People needed

43

Starts

2010-12-01

Expected to finish

2011-09-01

Last updated by the study team

2013-10-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Meharry Medical College — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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