Endometriosis Clinical Trial
Official title:
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
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
n/a
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