Health Condition 1: null- Benign Breast non discrete nodularity and pain
Conditions
Interventions
Intervention1: Centchroman (Saheli) or ormeloxifene: dosage of 30 mg, one tablet biweekly for 3 months
Control Intervention1: Placebo: made and supplied by CDRI, biweekely for 3 months
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: women (age group of 20-50 years with cyclical/non-cyclical breast pain and nodularity of more than three months duration.) attending the outpatient Departments of Surgery and Obstetrics and Gynecology and a specially established Breast Clinic at the Queen Mary?s Hospital, Lucknow
Exclusion criteria
Exclusion criteria: Patients with a discrete mass will be excluded if suspicious of cancer. Patients taking an alternative treatment will be excluded from the study. Those planning for pregnancy and are on some other oral contraceptive pills will not be registered for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement as assessed by daily breast pain chart and linear analogue scale will be the main outcome factor. Success will be defined as 50% reduction in the mean breast nodularity and pain score.Timepoint: The clinical examination will be done at 1, 2, 3 months while still on the drug or placebo and 4, 6 months after stopping the drug or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: The clinical examination will be done at 1, 2, 3 months while still on the drug or placebo and 4, 6 months after stopping the drug or placeboNone | — |
Countries
India
Contacts
Public ContactProf Sandeep Kumar
Professor of Surgery
Outcome results
None listed