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

NCT ID: NCT00275600

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cyclical Breast Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vitamin E, Evening Oil of Primrose, and Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

56 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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New Health International

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Sandhya Pruthi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1957-02

Identifier Type: -

Identifier Source: org_study_id