Efficacy and safety of ormeloxifene in management of menorrhagia: a pilot study.

OBJECTIVE

To assess the efficacy and safety of ormeloxifene (centchroman) in the medical management of menorrhagia.

METHODS

Forty-two women with menorrhagia were recruited for the study. 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 and 4 months of therapy, then at 3 and 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 pretreatment median PBAC score was 388 (range 169-835). Eighteen patients (42.9%) had amenorrhea with the therapy. Median PBAC reduced to 80 (range 0-730) and 5 (range 0-310) at 2 and 4 months, respectively (P-value <0.001); thus, the percentage reduction was 97.7% at 4 months. Seven patients (16.7%) had no response and three (7.1%) discontinued treatment before 4 months. During the 10-month study period, 21% of the patients underwent hysterectomy. Adverse effects included ovarian cyst (7.1%), cervical erosion and discharge (7.1%), gastric dyspepsia (4.8%), vague abdominal pain (4.8%) and headache (4.8%).

CONCLUSIONS

Ormeloxifene is an effective and safe therapeutic option for the medical management of menorrhagia.