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To compare the effects of two medicines in the amount of heavy menstrual bleeding and abdominal pain in women with uterine fibroid and adenomyosis

Comparative Efficacy of Ormeloxifene and Progestogens in the Management of Abnormal Uterine Bleeding - nil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060283
Enrollment
70
Registered
2023-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Interventions

Sponsors

Department of Obstetrics and gynaecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women of age >35 years presenting to the Gynaecological OPD with complaint of prolonged, heavy or irregular bleeding per vaginum who have been diagnosed with benign structural causes of Abnormal Uterine Bleeding such as adenomyosis and leiomyoma.

Exclusion criteria

Exclusion criteria: 1. Uterine/endocervical polyp 2. Women in whom endometrial biopsy shows a histopathology diagnosis of proliferative endometrium, endometrial hyperplasia, or malignancy. 3. Women with contraindications for treatment with progestogens 4. Women with previously failed medical management. 5. Women with active genital infection. 6. Women with abnormal renal or hepatic function tests, deranged coagulation profile, endocrinological or any other systemic illness that can cause Abnormal Uterine Bleeding. 7. Women complaining of infertility.

Design outcomes

Primary

MeasureTime frame
1. percentage change in Pictorial Blood loss assessment charts score at the end of 3 months of treatment. 2. Percentage improvement in pain as assessed by numerical pain rating scaleTimepoint: At the end of 1 month and 3 months of start of treatment.

Secondary

MeasureTime frame
1. Change in hemoglobin levels. 2. Patient satisfaction as assessed by patient satisfaction score. 3. Occurrence of any side effects with treatment.Timepoint: at the end of 3 months of initiation of treatment.

Countries

India

Contacts

Public ContactDr Bharti Goel

Government Medical College and Hospital, Chandigarh

bhartigoel14@gmail.com9646121606

Outcome results

None listed

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