At a glance
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A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.
In Brief
A Phase 4 clinical trial evaluating Tamoxifen and Evening Primrose Oil for Benign Breast Disease and 3 related conditions. Completed, enrolled 256 participants across 1 site.
Detailed Summary
The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy. To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.
Study Details
Timeline
Interventions
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.