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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

Primary Purpose

Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Depot medroxyprogesterone acetate
LNG-IUS
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-45year Pelvic pain VAS>50 Previous Sexual intercouse

Exclusion Criteria:

  • other genital tract disease causing pelvic pain Previous hromonal treament 3 month History of DMPA treatment failure WHO eligibility criteria 2009 categorized in 3-4 for DMPA and LNG-IUS user Fertility desire within 1 year Psychoneurosis Pregnant and breast fed women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    LNG-IUS

    DMPA

    Arm Description

    LNG IUS was hormonal containing IUD relased LNG at constant rate through out 5 year period. It was inserted only first time entry in the study.

    DMPA was given in trimonthly intramuscular injection.

    Outcomes

    Primary Outcome Measures

    Change baseline pain score assessed by visual analog scale after 6 month-use of both interventions

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2016
    Last Updated
    September 3, 2016
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02894151
    Brief Title
    Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective : To compare effectiveness of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain
    Detailed Description
    The participants were randomized into two treatment groups, by Block Of Four method, LNG-IUS and DMPA group. For the patients in the LNG-IUS group, a LNG-IUS (Mirena) was inserted. The system released the active ingredient LNG for up to five years at a virtually constant rate. For the patients in the Depot MPA Group, 150 mg depot MPA was given intramuscularly once every three months. All participants were recieved the individual calendars to record all vaginal bleeding occured during treatment. The amount of bleeding was described relative to normal menstruation of each patient; less than, same as, more than their baseline menses. To use easily, we assigned the symbols to represent quantity of vaginal bleeding as described. Each symbol was recorded every day except no bleeding, which was represented with blank space in the calendar. The bleeding pattern were assessed as bleeding rating score; less than normal menses = 1, same amount of normal menses = 2, more than normal menses = 3. No bleeding was defined as 30 consecutive days with bleeding score 0. The mean bleeding score was calculated by sum of the daily scores in each month period. Follow-up visits were scheduled three times at months 1, 3 and 6 after initial treatment. At each visit, VAS and bleeding pattern was recorded. Side-effects of the two therapies were checked. Patients were allowed to choose to withdraw from their designated therapy at any time. The follow-up was completed in May 2016 for the last patient. At the final visit, 6 months after treatment, all participants in both treatment groups were recorded the datas of blood pressure, body weight, transvaginal ultrasonography, lipid profiles and SF-36 quesionaires. In addition, all50 patients were asked whether they want to continue in the given treatement and the reason of discontinuation including the satisfaction scores during therapy were rated as 1-5 Likert-scale; 1-very dissatisfied, 2- dissatisfied, 3-neither satisfied/dissatisfied, 4-satisfied, 5-very satified.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LNG-IUS
    Arm Type
    Active Comparator
    Arm Description
    LNG IUS was hormonal containing IUD relased LNG at constant rate through out 5 year period. It was inserted only first time entry in the study.
    Arm Title
    DMPA
    Arm Type
    Active Comparator
    Arm Description
    DMPA was given in trimonthly intramuscular injection.
    Intervention Type
    Drug
    Intervention Name(s)
    Depot medroxyprogesterone acetate
    Intervention Type
    Device
    Intervention Name(s)
    LNG-IUS
    Primary Outcome Measure Information:
    Title
    Change baseline pain score assessed by visual analog scale after 6 month-use of both interventions
    Time Frame
    1year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age 18-45year Pelvic pain VAS>50 Previous Sexual intercouse Exclusion Criteria: other genital tract disease causing pelvic pain Previous hromonal treament 3 month History of DMPA treatment failure WHO eligibility criteria 2009 categorized in 3-4 for DMPA and LNG-IUS user Fertility desire within 1 year Psychoneurosis Pregnant and breast fed women

    12. IPD Sharing Statement

    Learn more about this trial

    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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