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Clinical Trials/NCT02534688
NCT02534688
Completed
Phase 4

Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients

King Chulalongkorn Memorial Hospital1 site in 1 country50 target enrollmentJune 2015
ConditionsEndometriosis
InterventionsLNG-IUSDMPA

Overview

Phase
Phase 4
Intervention
LNG-IUS
Conditions
Endometriosis
Sponsor
King Chulalongkorn Memorial Hospital
Enrollment
50
Locations
1
Primary Endpoint
Severity of pelvic pain : measured by visual analog scale
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kamolrat Daoudom

Effectiveness of levonorgestrel-intrauterine system (LNG-IUS) versus depot medroxyprogesterone acetate (DMPA) in treatment of pelvic pain in clinically diagnosed endometriotic patients

King Chulalongkorn Memorial Hospital

Eligibility Criteria

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

Arms & Interventions

LNG-IUS group

Single intervention LNG IUS

Intervention: LNG-IUS

DMPA group

Three intervention DmPA 12 wk apart

Intervention: DMPA

Outcomes

Primary Outcomes

Severity of pelvic pain : measured by visual analog scale

Time Frame: 6 months

Secondary Outcomes

  • Quality of life measured by Quesionaire SF 36 Thai version(6 months)
  • Lipid profile : total cholesterol, triglyceride, LDL, HDL(6months)

Study Sites (1)

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