Background: Mastalgia and fibrocystic breast disease is common occurance 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 November 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 (4.72to 0.84) at 24 week.15(30%)patients reported oligomenorrhoea.

Conclusion: Ormeloxifene showed significant efficacy  and safety for the treatment of mastalgia in  fibrocystic breast disease.