To compare the effects of two medicines in the amount of heavy menstrual bleeding and abdominal pain in women with uterine fibroid and adenomyosis
- Conditions
- Health Condition 1: N938- Other specified abnormal uterine and vaginal bleeding
- Registration Number
- CTRI/2023/11/060283
- Lead Sponsor
- Department of Obstetrics and gynaecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. percentage change in Pictorial Blood loss assessment charts score at the end of 3 months of treatment. <br/ ><br>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 Outcome Measures
Name Time Method 1. Change in hemoglobin levels. <br/ ><br>2. Patient satisfaction as assessed by patient satisfaction score. <br/ ><br>3. Occurrence of any side effects with treatment.Timepoint: at the end of 3 months of initiation of treatment.