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

NCT00999921 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2015-05-18

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical College and Hospital Kolkata

    lead OTHER

Principal Investigators

  • Md Tanveer Adil · Resident, Department of Surgery, Medical College and Hospital, Kolkata

  • Rumana Rahman · Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata

  • Soumen Das · Resident, Department of Surgery, Medical College and Hospital, Kolkata

  • Sudip Sarkar · Resident, Department of Surgery, Medical College and Hospital, Kolkata

  • Rupesh Kumar · Resident, Department of Surgery, Medical College and Hospital, Kolkata

  • Utpal De · Professor, Department of Surgery, Medical College and Hospital, Kolkata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-08-31
Completion
2015-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999921 on ClinicalTrials.gov