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

Status and phase: Completed; Phase 4

Conditions: Endometriosis

Treatments: Drug: LNG-IUS; Drug: DMPA

Study type: Interventional

Funder types: Other

Identifiers

NCT02534688

Kingchulalongkorn

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LNG-IUS group

Experimental group

Description:

Single intervention LNG IUS

Treatment:

Drug: LNG-IUS

DMPA group

Experimental group

Description:

Three intervention DmPA 12 wk apart

Treatment:

Drug: DMPA