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

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: LNG-IUS; Drug: DMPA

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memmorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LNG-IUS group; Single intervention LNG IUS	Drug: LNG-IUS
Experimental: DMPA group; Three intervention DmPA 12 wk apart	Drug: DMPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Severity of pelvic pain : measured by visual analog scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by Quesionaire SF 36 Thai version		6 months
Lipid profile : total cholesterol, triglyceride, LDL, HDL	Measured by blood collection in mg/dl	6months

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: KingChulalongkorn