Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Condition: Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS
MeSH terms: Pelvic Pain
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Depot medroxyprogesterone acetate; LNG-IUS
Intervention type(s): Drug; Device
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment