Comparison of oral tamoxifen. versus centchromon in reducing the size of breast fibroadenoma
Phase 3
Completed
- Conditions
- Health Condition 1: N602- Fibroadenosis of breast
- Registration Number
- CTRI/2022/02/040402
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
FNAC proven breast fibroadenoma of size < 5 cm
Exclusion Criteria
1. Past history of carcinoma breast
2. Family history of carcinoma breast in 1st degree relatives
3. History of PCOD, cervical dysplasia, and liver disease
4. Pregnancy and Lactating ladies
5. Recurrent fibroadenoma
6. Fibroadenoma associated with cellular atypic
7. Ladies planning pregnancy during the study period
8. BMI >35 kg/m2
9. Baseline endometrial thickness > 12 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the size of the breast fibroadenomaTimepoint: Reduction in the size of the breast fibroadenoma at 1 month, 3 months and 6 months
- Secondary Outcome Measures
Name Time Method changes in serum oestrogen levelTimepoint: at the completion of therapy at 03 months;Development of menstrual irregularities during the therapyTimepoint: at 01 month and 03 months of therapy;Effect on uterus and ovarian architecture on USGTimepoint: at completion of therapy at 03 months;Side effects and patient tolerance of the drugsTimepoint: at 01 week of therapy and then at 01 month and 03 months