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To compare the effects of two drugs in the management of abnormal uterine bleeding

Comparative efficacy of combined oral contraceptives and ormeloxifene in the management of abnormal uterine bleeding - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070066
Enrollment
80
Registered
2024-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Interventions

Intervention1: Ormeloxifene: Ormeloxifene will be given as medical treatment to patients diagnosed ultrasonographically with abnormal uterine bleeding due to structural causes. The drug will be admini

Sponsors

Government Medical College and Hospital Sector Chandigarh India Pincode
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women presenting to Gynaecological OPD with Abnormal Uterine Bleeding related to structural causes of the uterus, uterine fibroids and adenomyosis

Exclusion criteria

Exclusion criteria: 1. Women with bulky fibroids presenting with pressure symptoms who are not fit for medical management. 2. Submucosal fibroid type 0 and type 1. 3. Endometrial polyp, endometrial hyperplasia or malignancy. 4. Complex adnexal mass. 5. Acute AUB. 6. Abnormal renal or hepatic function tests. 7. Coagulopathy. 8. History of breast or genital malignancy. 9. Smoking. 10. Thromboembolic disease. 11. Diabetes, hypertension, migraine or epilepsy.

Design outcomes

Primary

MeasureTime frame
Change in amount and duration of menstrual blood loss by assessing pattern of periods through PBAC (Pictorial blood assessment charts) score.Timepoint: At the end of 2 months and 4 months after the start of treatment.—

Secondary

MeasureTime frame
1. Change in pain score after medication based on NRS (Numerical pain rating score). 2. Patient satisfaction with treatment using TSQM (Treatment satisfaction questionnaire for medication).Timepoint: At the end of 2 months and 4 months after the start of treatment.—

Countries

India

Contacts

Public ContactDr Bharti Goel

Government Medical College and Hospital, Sector 32, Chandigarh

bhartigoel14@gmail.com9646121606

Outcome results

None listed

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