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Comparing drug Ormeloxifene and Tranexamic Acid in heavy bleeding during menses in women with fibroids

Ormeloxifene versus Tranexamic Acid in the management of abnormal uterine bleeding due to uterine leiomyoma(AUB-L) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014695
Enrollment
180
Registered
2018-07-02
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: N938- Other specified abnormal uterine and vaginal bleeding Health Condition 2: null- Patients with heavy menstrual bleeding due to uterine fibroids planned for conservative management

Interventions

Intervention1: Ormeloxifene: Ormeloxifene will be administered in women with AUB-L as 60 mg twice weekly followed by 60mg once weekly for the entire duration of the menstrual cycle Control Interventio

Sponsors

Jenni Mariam George
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women in the reproductive age group who have completed their family or unmarried women not desirous of conception, with heavy menstrual bleeding due to uterine fibroids. Women with a pretreatment PBAC Score of more than or equal to 100.

Exclusion criteria

Exclusion criteria: 1. Irregular menstrual bleeding 2. Adnexal mass 3. Acute heavy bleeding necessitating hospitalization and immediate treatment with hormones 4. breast or genital tract malignancy, 5. Patients who are unable to followup after 3-6 months 6. Cervical dysplasia 7. Adenomyosis/endometrial polyp 8. Bleeding dyscrasias 9. Clinical evidence of jaundice or hepatic dysfunction, renal, cardiac or metabolic disorders 10. Known hypersensitivity to Tranexamic acid 11. Patients previously treated with Ormeloxifene 12. Women desirous of fertility 13. Patients on concurrent treatment with other drugs for AUB

Design outcomes

Primary

MeasureTime frame
Reduction in the menstrual blood lossTimepoint: 3 months, 6 months—

Secondary

MeasureTime frame
1.Effect on blood haemoglobin levels 2.Need for change of therapy or surgery while on the intervention 3.To monitor for adverse effects of either drugs Ormeloxifene and Tranexamic acid 4.Effect on the menstrual blood loss at the end of 3 months Timepoint: 0, 3, 6 months—

Countries

India

Contacts

Public ContactJenni Mariam George

CMC Vellore

vlondz@cmcvellore.ac.in9566571074

Outcome results

None listed

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