Objectives: Centchroman (Ormeloxifene) is a novel non-steroidal, selective antiestrogen. Because of its selective antiestrogen action, centchroman has been used for treatment of mastalgia and fibroadenoma.

Materials and methods: Benign breast disease patients up to 35 years of age attending our surgery outpatient department from August 2003 to September 2004 and fulfilling the inclusion criterion were included in this study. They were started on centchroman 30 mg on alternate days for a period of 3 months and were followed up for 6 months. Results were recorded as per clinical examination, visual analog scale (VAS) for pain, and ultrasonography for breast lump size.

Results: A total of 60 patients were included in this pilot study, 42 (70%) of whom had mastalgia with or without nodularity, and 18 (30%) had fibroadenoma. Noncyclical pain was recorded in 38 patients (90%), and cyclical pain was recorded in only 4 (10%) patients. A VAS score of 10 was recorded by 33 (80%) patients (severe pain), and the remaining 9 patients (20%) had VAS scores from 7 to 10. Fibroadenoma size ranged from 1.5 to 5 cm., single or multiple in one or both breasts. There was a good response in the mastalgia group, with a decrease in the VAS scoring from 10 to 3 in 90 % of the patients in the first week. Almost all of the patients were painless at the end of one month, with complete disappearance of the nodularity. In the fibroadenoma group there was a mixed response, with complete disappearance in 40%, partial regression in 20%, and no response at all in the remaining 40%. There were very few side effects.

Conclusions: Centchroman is a safe nonsteroidal drug for the treatment of mastalgia and fibroadenoma. It has shown good results in mastalgia and is a safe drug as compared to the drugs of choice used at present (danazole and bromocriptine). Further randomized studies are in progress and are needed to determine its definitive role in this patient group.