Medical Management of Dysfunctional Menorrhagia: Is Ormeloxifene a Safe and Efficacious Therapeutic Choice?

Abstract

ABSTRACT Objective To assess the efficacy and safety of ormeloxifene (centchroman) in the medical management of menorrhagia. Materials and methods One hundred and twenty women with menorrhagia were recruited for the study. One hundred women were analyzed. Ormeloxifene was given to each patient— 60 mg twice a week for 3 months and then once a week for 1 month. Patients were followed up at 2, 4, 6 months of therapy, then at 6 months after treatment was stopped. Menstrual blood loss (MBL) was measured objectively by a pictorial blood loss assessment chart (PBAC) score and subjectively by a visual analog scale (VAS). Results The mean age of the patients was 38.2 years with a mean parity of 2.4. The mean duration of menorrhagia was 13 months with 8 days as mean duration of bleeding and a mean cycle length of 26 days. 58.7% of the patients had bulky uterus on per vaginum examination done by the same observer. The mean endometrial thickness on transvaginal scan was 8.7 mm. The different study parameters were evaluated in patients treated with ormeloxifene and it showed a significant reduction in median PBAC score from 252 to 102.8, presence of clots from 64 to 12%, incidence of dysmenorrhea from 22 to 8% and mean endometrial thickness from 9.7 to 6.7 mm. There was also a significant elevation in the mean hemoglobin levels from 8.85 gm/dl to 10.6 gm/dl. The menstrual pattern of patients treated with ormeloxifene were encouraging. Eight percent of the women became ammenorhoeic after 6 months of therapy, 22% had scanty period, 56% had average flow, 12% had heavy from and only 2% had very heavy flow. It was further seen, that even though the PBAC score increased to 112.7 after stopping treatment for 6 months, but still it was lower than the pretreatment level (252). The percentage of patients who had an initial history of passage of clots during periods decreased from 64 to 12% and also 22% of patients who complained of mild to severe dysmenorrhea improved and only 8% of the patients complained of mild dysmenorrhea. Adverse effects Included ovarian cyst (14%), cervical erosion and discharge (11%), gastric upset (9%), headache (5%) and weight gain (3%). Conclusion Ormeloxifene is an effective and safe therapeutic option for the medical management of menorrhagia. How to cite this article Gupta N. Medical Management of Dysfunctional Menorrhagia: Is Ormeloxifene a Safe and Efficacious Therapeutic Choice? J South Asian Feder Menopause Soc 2014;2(2):65-70.