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

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ClinicalTrials.gov Identifier: NCT02534688
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Kamolrat Daoudom, King Chulalongkorn Memorial Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Severity of pelvic pain : measured by visual analog scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of life measured by Quesionaire SF 36 Thai version [ Time Frame: 6 months ]
  2. Lipid profile : total cholesterol, triglyceride, LDL, HDL [ Time Frame: 6months ]
    Measured by blood collection in mg/dl



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534688


Locations
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Thailand
King Chulalongkorn Memmorial hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital

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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     History of Changes
Other Study ID Numbers: Kingchulalongkorn
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Levonorgestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents