To Study the Effect of Ormeloxifene in Management of Perimenopausal Dysfunctional Uterine Bleeding

Abstract

OBJECTIVE:To study the effect of ormeloxifene in dysfunctional uterine bleeding in premenopausal age group by measuring menstrual blood loss by PBAC score, effect on blood hemoglobin levels and effect on endometrial thickness. METHODS: 35 cases of DUB of age 40 years and above coming to Gynecological OPD were recruited for study after applying exclusion criteria. 60 mg of Ormeloxifene was given twice a week for 3 months and then once a week for 1 month. Patients were followed-up at 1, 3 and 4 months of therapy and then at 3 months after treatment stopped. Menstrual blood loss was measured objectively by pictorial blood loss assessment chart (PBAC) score. RESULTS: The pretreatment median PBAC score was 587 with a range of 186-893. After 4 months of treatment, mean PBAC scores reduced to 76.94±77.73 with a mean change of 490.05±155.4. Which is statistically highly significant (P0.001). 26 (81.25%) patients were cured of menorrhagia at the end of 4 months of treatment. 2 patients had no response and underwent hysterectomy. Amenorrhoea occurred in 22 patients at the end of 4 months of therapy and persisted in 18 patients at 3 months of follow-up after therapy while 1 patient had PBAC scores in the heavy range but much less than her pretreatment levels. Adverse effects included vaginal discharge (15.62%), vague abdominal pain (12.5%), gastric upset (6.25%), headache (6.25%) and ovarian cyst (3.12%). CONCLUSION: Ormeloxifene is an effective and safe therapeutic option for the medical management of perimenopausal DUB.

Ormeloxifene in acute heavy menstrual bleeding in menopausal transition

“…The nonresponsiveness with ormeloxifene was variable from 3.3-16.7% in other studies. 25,27 Maximum women had reported amenorrhea (25.3%) as common side effect of drug in our study which was comparable with study of Agarwal et al, 30 which reported among 60 women (28.3%) and Kanchan et al, 25 (32.6%) among 50 women, which was welcoming for the age near menopause, whereas it was lower incidence compared to study by Anjum S et al, 31 (68.7%). Studies by other authors also mentioned about minor side effects not severe enough to the point of stopping ormeloxifene.…”

“…Studies by other authors also mentioned about minor side effects not severe enough to the point of stopping ormeloxifene. 19,30 Ormeloxifene therapy among women with AUB/DUB has been provided since 2000 and it can be started from anytime of cycle for HMB as endometrial haemostatic agent working within 48 hours of use. It is of advantage among menopause transition women being cardio-protective and prevents osteoporosis, compared to other drugs as well as budget friendly.…”