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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
LNG-IUS
DMPA
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • King Chulalongkorn Memmorial hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LNG-IUS group

DMPA group

Arm Description

Single intervention LNG IUS

Three intervention DmPA 12 wk apart

Outcomes

Primary Outcome Measures

Severity of pelvic pain : measured by visual analog scale

Secondary Outcome Measures

Quality of life measured by Quesionaire SF 36 Thai version
Lipid profile : total cholesterol, triglyceride, LDL, HDL
Measured by blood collection in mg/dl

Full Information

First Posted
August 19, 2015
Last Updated
March 16, 2017
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02534688
Brief Title
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Official Title
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LNG-IUS group
Arm Type
Experimental
Arm Description
Single intervention LNG IUS
Arm Title
DMPA group
Arm Type
Experimental
Arm Description
Three intervention DmPA 12 wk apart
Intervention Type
Drug
Intervention Name(s)
LNG-IUS
Intervention Type
Drug
Intervention Name(s)
DMPA
Primary Outcome Measure Information:
Title
Severity of pelvic pain : measured by visual analog scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life measured by Quesionaire SF 36 Thai version
Time Frame
6 months
Title
Lipid profile : total cholesterol, triglyceride, LDL, HDL
Description
Measured by blood collection in mg/dl
Time Frame
6months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
King Chulalongkorn Memmorial hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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