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

Cyclical Breast Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275600
• Other study ID #: 1957-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2006
• Last updated: November 25, 2009
• Start date: January 2003
• Est. completion date: September 2007

Study information

• Verified date: November 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 56 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cyclical Breast Pain
• Mastodynia

Intervention

Drug:
• Vitamin E, Evening Oil of Primrose, and Placebo

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	New Health International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test if Vitamin E improves cyclical breast pain
Primary	Test if Evening Oil of Primrose improves cyclical breast pain
Primary	Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain