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

Phase 2

Completed

• Conditions: Cyclical Breast Pain

• Registration Number: NCT00275600
• Lead Sponsor: Mayo Clinic

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 Description

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-25
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• 18 years or older
• premenopausal
• cyclical breast pain
• breast pain survey indicating 3 or more on scale of 1-10
• if > 40 years of age, need normal mammogram and/or ultrasound if indicated and if not done within the last year
• if < 40 years of age, a directed ultrasound in the area of pain
• can be on oral contraceptives

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States