The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.

Key facts

Study ID

NCT00566553

Run by

Mayo Clinic

People needed

39

Starts

2008-02-01

Expected to finish

2011-09-01

Last updated by the study team

2012-01-06

Who can join

Age: 55 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 55 - 75 years
• Able to understand and sign a consent form
• Postmenopausal (no menstrual period for 1 year or more)
• No personal cancer history (except for non-melanoma skin cancer)
• No hormone replacement therapy or anti-estrogens within 6 months of baseline

You may not qualify if…

• Known allergy to grapes or grape products
• Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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