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

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02534688

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: LNG-IUS Drug: DMPA	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Severity of pelvic pain : measured by visual analog scale [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Chulalongkorn Memmorial hospital	Bangkok		Thailand	10330

Sponsors and Collaborators

King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kamolrat Daoudom, 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

ClinicalTrials.gov Identifier:

NCT02534688

Other Study ID Numbers:

Kingchulalongkorn

First Posted:

Aug 28, 2015

Last Update Posted:

Mar 17, 2017

Last Verified:

Mar 1, 2017

Additional relevant MeSH terms:

Endometriosis

Pelvic Pain

Study Results

No Results Posted as of Mar 17, 2017