Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS Clinical Trial
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment