A randomized trial to compare the effectiveness of Levonorgestrel-releasing intrauterine device and Gonadotropin-releasing hormone agonist in the treatment of adenomyosis in women nearing menopause (40-52 years)
Phase 4
- Conditions
- Health Condition 1: N924- Excessive bleeding in the premenopausal period
- Registration Number
- CTRI/2022/12/047926
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Women in the perimenopausal (40-52 years) age group presenting to us with complaints of
heavy menstrual bleeding (with PBAC score more than or equal to 100) with or without pain and were
diagnosed with adenomyosis on USG.
Exclusion Criteria
-Patient allergic to GnRH agonist (leuprolide).
-Patient on anticoagulants of any type like heparin, LMWH, warfarin, etc.
-Patients who are diagnosed with any other gynecological pathology other than
adenomyosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effectiveness of Levonorgestrel-releasing intrauterine device and Gonadotropin- <br/ ><br>releasing hormone agonist in reducing heavy menstrual bleeding as assessed by Pictorial blood <br/ ><br>loss assessment chart score in patients with adenomyosis in the perimenopausal age group.Timepoint: Pictorial blood loss assessment chart score will be calculated at the first visit, at 3 months and 6 months follow-up.
- Secondary Outcome Measures
Name Time Method To compare the Levonorgestrel-releasing intrauterine device and Gonadotropin-releasing <br/ ><br>hormone agonist in <br/ ><br>- Pain reduction assessed by Visual analog scale score. <br/ ><br>- In uterine volume reduction.Timepoint: Visual analog score and uterine volume will be assessed at the first visit, at 3 months and 6 months follow-up.