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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02534688 |
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Date of registration:
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19/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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June 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02534688 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis
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Intervention(s)
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Drug: LNG-IUS
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Drug: DMPA
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Primary Outcome(s)
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Severity of pelvic pain : measured by visual analog scale
[Time Frame: 6 months]
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Secondary Outcome(s)
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Lipid profile : total cholesterol, triglyceride, LDL, HDL
[Time Frame: 6months]
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Quality of life measured by Quesionaire SF 36 Thai version
[Time Frame: 6 months]
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Secondary ID(s)
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Kingchulalongkorn
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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