Clinical Trial: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain

Brief Summary: This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on cyclical breast pain.

Detailed Summary: Cyclical mastalgia is a common complaint of women presenting to their primary care physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated with hormonal fluctuations during the menstrual cycle. A clinical breast examination and sometimes additional imaging, such as sonography or mammography, is required as part of the evaluation to exclude malignancy. For most women, the symptoms are effectively managed with reassurance and conservative treatment measures such as the use of a supportive bra or over the counter pain medication such as acetaminophen or anti-inflammatories. However, a small number of women will require additional drug treatment with danazol after failing to respond to conservative measures. Unfortunately, danazol is associated with significant side effects. In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and Evening oil of primrose (EOP) either as single agents or in combination. These over the counter supplements are readily available, acceptable due to minial side effects and appear to lead to significant reduction in breast pain. We propose a randomized placebo controlled trial to determine if any vitamin E or EOP or the combination of both are effective in managing cyclical breast pain.
Sponsor: Mayo Clinic

Current Primary Outcome:

  • Test if Vitamin E improves cyclical breast pain
  • Test if Evening Oil of Primrose improves cyclical breast pain
  • Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: January 10, 2006
Date Started: January 2003
Date Completion:
Last Updated: November 25, 2009
Last Verified: November 2009