NCT00999921

Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Medical College and Hospital Kolkata · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Conditions

• Benign Breast Disease
• Fibrocystic Disease of Breast
• Fibroadenoma
• Mastalgia

Interventions

Type	Name	Description
DRUG	Tamoxifen	Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
DRUG	Evening Primrose Oil	Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-08-01
• Completion: 2015-01-01
• First posted: 2009-10-22
• Last updated: 2015-05-18
• Results posted: 2015-04-29

Locations

1 site across 1 country: India