Mirena versus Ormeloxifene in AUB.

Efficacy of Mirena versus Ormeloxifene in management of Abnormal uterine bleeding (AUB) . - MIROR

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027567

Enrollment

Registered

2020-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: ormeloxifene: 60mg of ormeloxifene, twice weekly for 12 weeks, then once weekly. Control Intervention1: of Mirena LNG-IUS: Mirena LNG-IUS (52mg

20 mcg per day) placed in an OPD set-up

Eligibility

Inclusion criteria

Inclusion criteria: Women in the pre-menopausal age group who have Abnormal uterine bleeding. Completed family/not desirous of conception.

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

India

Contacts

Public ContactEmily Divya Ebenezer

Christian Medical College, Vellore

Og2@cmcvellore.ac.in04162283397

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026