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

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ClinicalTrials.gov Identifier: NCT00275600
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : November 26, 2009
Sponsor:
Collaborator:
New Health International
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cyclical Breast Pain Drug: Vitamin E, Evening Oil of Primrose, and Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain
Study Start Date : January 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007





Primary Outcome Measures :
  1. Test if Vitamin E improves cyclical breast pain
  2. Test if Evening Oil of Primrose improves cyclical breast pain
  3. Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain


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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275600


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
New Health International
Investigators
Principal Investigator: Sandhya Pruthi, M.D. Mayo Clinic

Responsible Party: Sandhya Pruthi, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275600     History of Changes
Other Study ID Numbers: 1957-02
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Mastodynia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents