Health Condition 1: D249- Benign neoplasm of unspecified breast
Conditions
Interventions
Intervention1: Arm 1: Total Estrogen Blockade (TEB): i/v Leuprolide 3.75mg intermuscular once a month for three months
Tab. Ormeloxifene 30mg per oral daily for 3 months
Control Intervention1: Arm 2:
Sponsors
Pt JNM Medical College Raipur
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age Less Than 20 Years 2. Histologically Confirmed Fibroadenoma of more than 5 cm size 3. Patients with written informed consent or consent from a guardian for girls below age 18 years.
Exclusion criteria
Exclusion criteria: 1. Past history or family history of cancer breast 2. Patient presenting with Polycystic Ovarian Syndrome ( PCOS) 3. Liver disease 4. Complex fibroadenoma or with atypia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in fibroadenoma size (measured via ultrasound or clinical examination)Timepoint: Baseline, 1 month, 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse effects (hot flashes, menstrual irregularities, etc.).Timepoint: Baseline, 1 month, 3 months, end of trial.;Complete regression rate (%) of fibroadenoma in each arm.Timepoint: Baseline, 1 month, 3 months, 6 months | — |
Countries
India
Contacts
Public ContactDr Manju Singh
Pt. J.N.M. Medical College, Raipur
Outcome results
None listed