Publication:

Efficacy and safety of ormeloxifene, a selective estrogen receptor modulator in management of dysfunctional uterine bleeding in perimenopausal patients: a prospective interventional study

Background Dysfunctional uterine bleeding (DUB) is one of the most common menstrual disorder of women in any age group and is a diagnosis of exclusion. Medical management of menorrhagia is a difficult task as there are wide variations in the available drugs and a lot of different regimes are available. Present study evaluates efficacy and safety of ormeloxifene a selective estrogen receptor modulator (SERMs) in treatment of dysfunctional uterine bleeding in perimenopausal women.

Methods The study was conducted on 120 patients in the age group of 40-55 years who were treated with 60 mg ormeloxifene twice a week for first 12 weeks and once weekly for next 12 weeks. The primary outcome measures were menstrual blood loss (assessed by pictorial blood assessment chart score), hemoglobin concentration and endometrial thickness. The secondary outcome measures were aceptability and side effects of ormeloxifene.

Results 86.66% of women showed marked improvement in symptoms. Mean endometrial thickness decreased significantly from 9.825 mm to 6.25 mm after 6 months of treatment (p value <0.001). A significant decrease in median PBAC score (p value <0.001) was observed. Also, the mean haemoglobin level increased significantly from 8.03 g/dl to 9.60 g/dl (p value <0.001). Most common side effect reported was amenorrhoea (16%). 4% patient not relieved underwent hysterectomy.

Conclusions Ormeloxifene could be the drug of choice in patients with DUB. It is safe, cost-effective with manageable side effects. The therapy has facilitated compliance, tolerability and reduction of symptoms resulting in adherence towards the treatment.