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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00275600
Enrollment
82
Registered
2006-01-12
Start date
2003-01-31
Completion date
2007-09-30
Last updated
2009-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 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.

Interventions

DRUGVitamin E, Evening Oil of Primrose, and Placebo

Sponsors

New Health International
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 56 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026