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

This study has been completed.
Sponsor:
Collaborator:
New Health International
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275600
First received: January 10, 2006
Last updated: November 25, 2009
Last verified: November 2009
History of Changes

January 10, 2006
November 25, 2009
January 2003
September 2007   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00275600 on ClinicalTrials.gov Archive Site
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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

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

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cyclical Breast Pain
Drug: Vitamin E, Evening Oil of Primrose, and Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Female
18 Years to 56 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275600
1957-02
Not Provided
Sandhya Pruthi, MD, Mayo Clinic
Mayo Clinic
New Health International
Principal Investigator: Sandhya Pruthi, M.D. Mayo Clinic
Mayo Clinic
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP