Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02534688
Enrollment
50
Registered
2015-08-28
Start date
2015-06-30
Completion date
2016-05-31
Last updated
2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

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

Interventions

DRUGDMPA

Sponsors

King Chulalongkorn Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Severity of pelvic pain : measured by visual analog scale6 months

Secondary

MeasureTime frameDescription
Quality of life measured by Quesionaire SF 36 Thai version6 months
Lipid profile : total cholesterol, triglyceride, LDL, HDL6monthsMeasured by blood collection in mg/dl

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026