Comparing drug Ormeloxifene and Tranexamic Acid in heavy bleeding during menses in women with fibroids
- Conditions
- Health Condition 1: N938- Other specified abnormal uterine and vaginal bleedingHealth Condition 2: null- Patients with heavy menstrual bleeding due to uterine fibroids planned for conservative management
- Registration Number
- CTRI/2018/07/014695
- Lead Sponsor
- Jenni Mariam George
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the menstrual blood lossTimepoint: 3 months, 6 months
- Secondary Outcome Measures
Name Time Method 1.Effect on blood haemoglobin levels <br/ ><br>2.Need for change of therapy <br/ ><br> or surgery while on the intervention <br/ ><br>3.To monitor for adverse effects of either drugs Ormeloxifene and Tranexamic acid <br/ ><br>4.Effect on the menstrual blood loss at the end of 3 months <br/ ><br>Timepoint: 0, 3, 6 months