NCT00275600

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

Completed Phase 2/Phase 3 Last updated 25 November 2009

What this trial tests

Phase 2/Phase 3 trial testing Vitamin E, Evening Oil of Primrose, and Placebo in Cyclical Breast Pain in 82 participants. Completed in 1 September 2007.

Timeline

1 January 2003

Primary endpoint
1 September 2007

1 September 2007

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	82
Start date	1 January 2003
Primary completion	1 September 2007
Estimated completion	1 September 2007
Sites	1 location across United States

Drugs / interventions tested

• Vitamin E, Evening Oil of Primrose, and Placebo — full drug profile →

Conditions studied

• Cyclical Breast Pain — all drugs for Cyclical Breast Pain →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 56, female only, with Cyclical Breast Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.