Efficacy and Safety of Ormeloxifene in Regression of Mastalgia Associated with Fibrocystic Disease of Breast

Mastalgia and fibrocystic breast disease is common occurrence in women of reproductive age group. Ormeloxifene is a weak oestrogen receptor (ER) agonist, a strong ER antagonist (SERA) and therefore a selective ER modulator (SERM) used in the treatment of the disease. Aim of study was to see the efficacy and safety of Ormeloxifene in regression of mastalgia associated with fibrocystic breast disease. Material and method- This was prospective trial, conducted in NMCH, Patna from December 2015 to March 2017. Fifty women of age 20-40 year with mastalgia associated with fibrocyctic disease of breast with VAS score more than 2 were treated with Ormeloxifene 30mg once daily on alternate days for a period of 3 months. Follow up was done monthly for 3 month and then at 6 month with Visual Analogue Scale (VAS) for pain and for side effect. Results-Total 63 patients were enrolled in the study.13 patients left during trial.50 patients completed the trial. The mean age was 34 year. The mean pain level was continuously decreased over 5 visit (4.72 to 0.51) at 24 week.15 (30 %) patients reported oligomenorrhoea. Conclusion Ormeloxifene showed significant efficacy and safety for the treatment of mastalgia in fibrocystic breast disease.