Conditions: Benign Breast Disease Fibrocystic Disease of Breast Fibroadenoma Mastalgia
Keywords: Fibrocystic Breast Disease Fibroadenoma Mastalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 256
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months arm 2: 1000 mg daily for 3 months

Interventions: intervention 1: Tamoxifen intervention 2: Evening Primrose Oil
Intervention descriptions: intervention 1: Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles. intervention 2: Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Protocol document: