Comparing two drugs for a treatment
Phase 3
- Conditions
- Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2024/03/064357
- Lead Sponsor
- SRM college of pharamacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
patients diagnosed with adenomyosis in ultrasonography
patients willing to participate
patient willing to be on contraceptives during study period
Exclusion Criteria
patients planning for pregnancy
pregnant and lactating patients
patients with mental illness
patients who are already in any other hormonal treatment for adenomyosis
patients who have undergone surgery (less than 6 months)
patients diagnosed with mild hepatic dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the change in pain as measured by Wong Bakers FACES pain rating scale in patients receiving DMPA + Atorvastatin and DMPA alone <br/ ><br> <br/ ><br>To assess the change in abnormal uterine bleeding as measured by the UFS-QOL questionnaire in patients receiving DMPA + Atorvastatin and DMPA aloneTimepoint: Patients will be followed at the end of 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method To assess the change in uterine volume and vascularity by measuring the pulsatility index by transvaginal USG (MUSA criteria) <br/ ><br> <br/ ><br>To assess the quality of life in patients using UFS-QOL questionnaire <br/ ><br> <br/ ><br>To assess the Hb level on day 2 as measured by blood samples in patients with adenomyosis <br/ ><br> <br/ ><br>Timepoint: Patients will be followed at the end of 4, 8 and 12 weeks