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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534688
• Other study ID #: Kingchulalongkorn
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2015
• Last updated: March 16, 2017
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Drug:
• LNG-IUS

• DMPA

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memmorial hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of pelvic pain : measured by visual analog scale		6 months
Secondary	Quality of life measured by Quesionaire SF 36 Thai version		6 months
Secondary	Lipid profile : total cholesterol, triglyceride, LDL, HDL	Measured by blood collection in mg/dl	6months