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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LNG-IUS group

Single intervention LNG IUS

Group Type EXPERIMENTAL

LNG-IUS

Intervention Type DRUG

DMPA group

Three intervention DmPA 12 wk apart

Group Type EXPERIMENTAL

DMPA

Intervention Type DRUG

Interventions

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LNG-IUS

Intervention Type DRUG

DMPA

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Kamolrat Daoudom

Effectiveness of levonorgestrel-intrauterine system (LNG-IUS) versus depot medroxyprogesterone acetate (DMPA) in treatment of pelvic pain in clinically diagnosed endometriotic patients

Responsibility Role PRINCIPAL_INVESTIGATOR