Effectiveness of Ormeloxifene versus Norethisterone acetate for control of bleeding in women with abnormal uterine bleeding– A randomized control trial.

This study is a randomized trial to compare the efficacy of ormeloxifene and norethisterone acetate in women with abnormal uterine bleeding. â€¢The women will randomly be allocated to 2 groups of 30 each. Group O will be given Ormeloxifene tablet 60mg stat and Group N will be given Tab norethisterone acetate 5mg 2tab TDS. We will see for control of bleeding in both the group. If in any group bleeding is not controlled we will give tranexamic acid injectable or oral. After active bleeding controlled we will give in Group O tab Ormeloxifene 60mg twice a week for 12 weeks followed by 60mg once a week for next 12 weeks. Group N will be given Norethisterone acetate tablet 5mg twice a day for 21 days for 6 cycles. Follow up will be done at 1, 3, 6 months. At each visit a detailed menstrual history will be taken, PBAC score will be calculated. â€¢The primary outcome measures will be reduction in amount of menstrual blood loss (assessed by fall in PBAC score and patient’s subjective assessment),hemoglobin concentration and decrease in endometrial thickness in proliferative phase on transvaginal ultrasound.Secondary outcome measures will be the side effect which will be assessed at 1month revisit.