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临床试验/NCT02894151
NCT02894151已完成2 期

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

Chulalongkorn University0 个研究点目标入组 50 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
主要终点
Change baseline pain score assessed by visual analog scale after 6 month-use of both interventions

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

LNG-IUS

Active Comparator

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.

干预措施: LNG-IUS (Device)

DMPA

Active Comparator

DMPA was given in trimonthly intramuscular injection.

干预措施: Depot medroxyprogesterone acetate (Drug)

结局指标

主要结局

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

时间窗: 1year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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