Publication:

Ormeloxifene in the management of dysfunctional uterine bleeding

Background Dysfunctional Uterine Bleeding (DUB), is the commonest cause of Abnormal Uterine Bleeding (AUB). It causes morbidity, anaemia, and unnecessary hysterectomies in women of fertile age group. This study attempts to study efficacy of medical management especially Selective Estrogen Receptor Modulator (SERM) namely Ormeloxefine (ORM) (Sevista®) in Perimenopausal women. Ormeloxifene was marketed in India for contraception under brand names Centron, Saheli, Choice-7, Novex and Novex-DS. It’s a benzopyran derivative also known as Centchroman which causes asynchronousity between ovulation and menstrual cycles possibly because of both estrogenic and anti-estrogenic actions. It has been known to cause delay in ovulation in clinical trials; however, majority have been unaffected. It causes delay in proliferation of endometrium thereby causing asynchronous cycles. It also improves motility of ciliary lining of Fallopian tubes thereby reducing the chances of implantation of fertilized egg.

Methods This study is aimed at evaluation of subjective and objective stastical benefits and side effects in treatment of DUB in perimenopausal age group with ORM and commonly used 19 nortestosterone compound (progesterone); Norethisterone (NET).

Results Primary outcome were analyzed at the end of every 3 months and at the end of one year finally. Secondary outcomes of the study in each arm were also assessed. There was stastically significant increase in Hb and stastically significant decrease in ET. Data analysis was done for variables in each arm by t-test to estimate the mean, median, range P and t value for a conclusion. Differences were taken as significant when P<0.05.

Conclusions ORM is a safe, cost effective, non-steroidal, non-hormonal drug with convenient dosage and better compliance for medical management of perimenopausal DUB with minimum focal pathology. Side effects observed need more evaluation with larger sample size to be statistically significant.