Mirena versus Ormeloxifene in AUB.

Phase 1

Conditions: Health Condition 1: N921- Excessive and frequent menstruation with irregular cycleHealth Condition 2: N920- Excessive and frequent menstruation with regular cycleHealth Condition 3: N924- Excessive bleeding in the premenopausal periodHealth Condition 4: N926- Irregular menstruation, unspecifiedHealth Condition 5: N925- Other specified irregular menstruation

Recruitment & Eligibility

Inclusion Criteria

Women in the pre-menopausal age group who have Abnormal uterine bleeding.

Completed family/not desirous of conception.

Exclusion Criteria

Patients with acute heavy bleeding requiring hospitalization and immediate treatment with hormones.

Patients requiring blood transfusion as a part of management.

Uterine size 14 weeks or more

Any fibroids pushing/indenting the endometrial cavity

Patients with Known blood dyscrasias / coagulopathies

Breast/genital tract malignancies

Adnexal mass

Endometrial polyp

Previous treatment with ormeloxifene

Clinical evidence of hepatic dysfunction, renal, cardiac or metabolic disorders.

Patients on concurrent treatment with other drugs for AUB.

Primary Outcome Measures

Name	Time	Method
PRIMARY: Reduction in menstrual blood loss denoted by change in PBAC score <br/ ><br>SECONDARY: Change in hemoglobin levels <br/ ><br> Need for alteration in therapy or surgical intervention during treatment <br/ ><br> Monitor for side effects of ormeloxifene/ mirena during the course of treatment. <br/ ><br>Incidence of unscheduled bleeding. <br/ ><br>Success in treatment as denoted by a reduction of PBAC score to 100. <br/ ><br> <br/ ><br>Timepoint: recruitment : 12/08/2020 to 31/01/2021 <br/ ><br>followup :01/02/2020 to 31/07/2021 <br/ ><br>data analysis: 01/08/2021 to 15/09/2020 <br/ ><br>write up: 1/09/2021 to 30/10/2021

Secondary Outcome Measures

Name	Time	Method
Change in hemoglobin levels <br/ ><br> Need for alteration in therapy or surgical intervention during treatment <br/ ><br> Monitor for side effects of ormeloxifene/ mirena during the course of treatment. <br/ ><br>Incidence of unscheduled bleeding. <br/ ><br>Success in treatment as denoted by a reduction of PBAC score to 100. <br/ ><br> <br/ ><br>Timepoint: analyzed at 6 months after recruitment