Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
- Registration Number
- NCT02534688
- Lead Sponsor
- King Chulalongkorn Memorial Hospital
- Brief Summary
randomized controlled trial
Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule Cul-de-sac nodularity Endometrioma detected by ultrasonography size \< 4 cm
Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS \>50 Previous sexual intercourse
Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year
Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA
Secondary objective To compare side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain
Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most pain
Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3 satisfied 4 very satisfied Continuation rate Endometrioma size reduction
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Female age 18-45 yr
- Moderate to severe pelvic pain categorized by VAS >50
- Previous sexual intercourse
- Co-existing other genital tract disease associated pain
- Previous hormonal use within 3 months
- History of DMPA treatment failure
- WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4
- Fertility desire in upcoming 1 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LNG-IUS group LNG-IUS Single intervention LNG IUS DMPA group DMPA Three intervention DmPA 12 wk apart
- Primary Outcome Measures
Name Time Method Severity of pelvic pain : measured by visual analog scale 6 months
- Secondary Outcome Measures
Name Time Method Quality of life measured by Quesionaire SF 36 Thai version 6 months Lipid profile : total cholesterol, triglyceride, LDL, HDL 6months Measured by blood collection in mg/dl
Trial Locations
- Locations (1)
King Chulalongkorn Memmorial hospital
🇹🇭Bangkok, Thailand
King Chulalongkorn Memmorial hospital🇹🇭Bangkok, Thailand