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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Md Tanveer Adil, Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier:
NCT00999921
First received: October 21, 2009
Last updated: April 28, 2015
Last verified: April 2015
Results First Received: November 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Benign Breast Disease
Fibrocystic Disease of Breast
Fibroadenoma
Mastalgia
Interventions: Drug: Tamoxifen
Drug: Evening Primrose Oil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Premenopausal women with Benign Breast Disease and who belong to non-high risk group for breast cancer were included in the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Postmenopausal women, premenopausal women with pregnancy or other contraindications to tamoxifen, girls less than 15 years, very large lesions, high risk patients with epitheliosis, atypia or atypical hyperplasia or prone to develop malignancy and patients unwilling to undergo treatment were excluded from the study

Reporting Groups
  Description
Tamoxifen Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
Evening Primrose Oil Evening Primrose Oil 1000 mg daily for 3 months

Participant Flow:   Overall Study
    Tamoxifen     Evening Primrose Oil  
STARTED     127     129  
COMPLETED     117     110  
NOT COMPLETED     10     19  
Lost to Follow-up                 10                 19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tamoxifen Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
Evening Primrose Oil Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
Total Total of all reporting groups

Baseline Measures
    Tamoxifen     Evening Primrose Oil     Total  
Number of Participants  
[units: participants]
  127     129     256  
Age  
[units: participants]
     
<=18 years     3     2     5  
Between 18 and 65 years     124     127     251  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  25.38  (4.2)     25.16  (3.8)     25.27  (4.0)  
Gender  
[units: participants]
     
Female     127     129     256  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
India     127     129     256  



  Outcome Measures
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1.  Primary:   Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)   [ Time Frame: 3 months ]

2.  Primary:   Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).   [ Time Frame: 3 months ]

3.  Secondary:   Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Md Tanveer Adil
Organization: Medical College and Hospital Kolkata
phone: 0091-9830154566
e-mail: tanveer.cmc@gmail.com


Publications:

Responsible Party: Md Tanveer Adil, Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier: NCT00999921     History of Changes
Other Study ID Numbers: MSVP-107/08
Study First Received: October 21, 2009
Results First Received: November 15, 2010
Last Updated: April 28, 2015
Health Authority: India: Ministry of Health