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

NCT02534688 | Completed Phase 4

• 1 other identifier: Kingchulalongkorn
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Severity of pelvic pain : measured by visual analog scale

  6 months

Secondary Outcomes (2)

• Quality of life measured by Quesionaire SF 36 Thai version

  6 months

• Lipid profile : total cholesterol, triglyceride, LDL, HDL

  6months

Study Arms (2)

LNG-IUS group

EXPERIMENTAL

Single intervention LNG IUS

Drug: LNG-IUS

DMPA group

EXPERIMENTAL

Three intervention DmPA 12 wk apart

Drug: DMPA

Interventions

LNG-IUS DRUG

LNG-IUS group

DMPA DRUG

DMPA group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memmorial hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Endometriosis

Interventions

N,N-dimethyl-4-anisidine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effectiveness of levonorgestrel-intrauterine system (LNG-IUS) versus depot medroxyprogesterone acetate (DMPA) in treatment of pelvic pain in clinically diagnosed endometriotic patients

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 28, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

TH (1)