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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02534688
Other study ID # Kingchulalongkorn
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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