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临床试验/NCT02534688
NCT02534688已完成4 期

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 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Severity of pelvic pain : measured by visual analog scale

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female age 18-45 yr
  • Moderate to severe pelvic pain categorized by VAS >50
  • Previous sexual intercourse

排除标准

  • 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

研究组 & 干预措施

LNG-IUS group

Experimental

Single intervention LNG IUS

干预措施: LNG-IUS (Drug)

DMPA group

Experimental

Three intervention DmPA 12 wk apart

干预措施: DMPA (Drug)

结局指标

主要结局

Severity of pelvic pain : measured by visual analog scale

时间窗: 6 months

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (1)

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