Health Condition 1: N602- Fibroadenosis of breast
Conditions
Interventions
Intervention1: Tamoxifen (10 mg): Oral Tamoxifen 10 mg once daily dose for 03 months
Control Intervention1: Centchromon (30 mg): Oral Centchromon 30 mg OD for a duration of 03 months
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: FNAC proven breast fibroadenoma of size < 5 cm
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Debajyoti Mohanty
All India Institute of Medical Sciences, Raipur
Outcome results
None listed