Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized clinical trial the use of levonorgestrel releasing intrauterine system.

      Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine
      system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the
      control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.
    

Detailed description: 
      Randomized clinical trial the use of levonorgestrel releasing intrauterine system.

      Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine
      system (LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the
      control of chronic pelvic pain and / or dysmenorrhea in women with endometriosis.

      Methods: Will be assessed 103 women, aged 18-45 years, diagnosis of endometriosis confirmed
      by laparoscopy or laparotomy that presents chronic pelvic pain and / or dysmenorrhea. The
      study will be experimental, randomized , (5' women will be allocated to the LNG-IUS and 52
      women will use the implant subdermal ENG). Women will be invited to participate in the study
      on the day and having the Family Planning Clinic with pelvic pain complaints and / or
      dysmenorrhea with a confirmed diagnosis of endometriosis in search of inserting a LNG-IUS.
      That day will be invited to be allocated by lottery (through a system of computer generated
      randomization; with opaque and sealed envelopes), the group that will use LNG-IUS or
      subdermal implant ENG. At the inclusion in the study will be held the insertion of the
      LNG-IUS or ENG implant and on this day the pain will be evaluated by visual analogue scale
      (VAS) of pain and applied the evaluation questionnaire of endometriosis. It will be a
      calendar to record delivered daily bleeding and EVA for daily assessment of pain. Women will
      return each 30 days (± 3 days) where the pain of registration will be evaluated by EVA and
      will be collected the bleeding and delivered a new calendar for the next 30 days. The end of
      the study It is expected to 180 days post-insertion of the LNG-IUS or the implant and, in the
      latter evaluation, will again be applied questionnaire. Cancer antigen 125 (CA-125), CD23 and
      endometrial biopsy will be evaluated at baseline and at last follow-up ( +/- 180 days).

      Inclusion criteria:

        -  Women aged 18 to 45

        -  Absence of pregnancy

        -  Patients with chronic pelvic pain and / or dysmenorrhea with pain scores ≥ 4 on EVA pain
           and surgical and histopathological diagnosis of endometriosis in 14 last three months to
           two years, according to the current classification of the American Society for
           Reproductive Medicine and

        -  Accept participate and sign the consent form and clarified.
    

Intervention name(s): Levonorgestrel; Etonogestrel
Intervention type(s): Drug; Drug
Intervention description(s): 20μg/day.; 20μg/day.
Other intervention name(s): levonorgestrel releasing intrauterine system; Mirena; Implanon
Intervention MeSH terms: Levonorgestrel; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment