Comparative Efficacy of Ormeloxifene Versus Norethisterone Acetate in the Management of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

Background Abnormal uterine bleeding (AUB) impacts women's health and quality of life globally. Pharmacological management has prioritized hormonal agents such as norethisterone acetate; however, selective estrogen receptor modulators such as ormeloxifene have emerged as potential alternatives. Hence, this study aimed to assess and compare the effectiveness and safety of ormeloxifene and norethisterone acetate in women with AUB. Methodology This parallel, open-label, randomized controlled trial conducted at a tertiary center in central India included 60 women aged 21-47 years with AUB. Thirty participants each were assigned to ormeloxifene (60 mg twice weekly for 12 weeks, followed by once weekly for 12 weeks) or norethisterone acetate (5 mg twice daily for 21 days per cycle for six cycles). Primary endpoints included changes in pictorial blood loss assessment chart (PBAC) scores, hemoglobin concentration, and endometrial thickness (ET). Safety and the need for a hysterectomy were also assessed. Results Both groups were demographically comparable. The mean reduction in PBAC score at six months favored the ormeloxifene arm (-124.63 ± 14.65 vs. -103.73 ± 18.33, p < 0.001). The mean hemoglobin increase was significantly greater with ormeloxifene (2.26 ± 0.43 g/dL vs. 1.91 ± 0.66 g/dL, p = 0.019). ET reduction at six months was also superior in the ormeloxifene group (-8.90 ± 3.74 mm versus -6.20 ± 2.66 mm, p = 0.002). Side effects were infrequent and well-controlled, and surgical intervention was rarely required. Conclusions Ormeloxifene demonstrates superior efficacy in reducing menstrual blood loss, improving anemia, and suppressing endometrial proliferation in women with AUB compared to norethisterone acetate, with an acceptable safety profile.