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

Primary Purpose

Cyclical Breast Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin E, Evening Oil of Primrose, and Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyclical Breast Pain

Eligibility Criteria

18 Years - 56 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
November 25, 2009
Sponsor
Mayo Clinic
Collaborators
New Health International
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1. Study Identification

Unique Protocol Identification Number
NCT00275600
Brief Title
Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain
Official Title
Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
New Health International

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclical Breast Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vitamin E, Evening Oil of Primrose, and Placebo
Primary Outcome Measure Information:
Title
Test if Vitamin E improves cyclical breast pain
Title
Test if Evening Oil of Primrose improves cyclical breast pain
Title
Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandhya Pruthi, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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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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