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Randomized experimental study of the use of the levonorgestrel-releasing intrauterine system versus the etonogestrel-releasing subdermal implant on the control of pelvic pain associated to endometriosis

Grant number: 15/10021-0
Support type:Regular Research Grants
Duration: March 01, 2016 - February 28, 2018
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Luis Guillermo Bahamondes
Grantee:Luis Guillermo Bahamondes
Home Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Assoc. researchers: Nelsilene Mota Carvalho Tavares

Abstract

SummaryObjetctives: Asess and compare the efficacy of the levonorgestrel-releasing intaruterine system (LNG-IUS) versus the etonogetrel (ENG)-releasing subdermal implant on the control of chronic pelvic pain and/or dysmenorrhea in women with endometriosis. Material and methods: One hundred women aged 18-45 yeras old will be enrolled, with confirmed diagnosis of endometriosis by laparoscopy or laparotomy with chronic pelvic pain and/or dysmenorrhea. The study will be experimental, randomized, comparative, (50 women will be allocated to the LNG-IUS and 50 women to the ENG-implant). The women will be invited to participate at the day in which they consulted at the Family Planning clinic with complaint of chronic pelvic pain and/or dysmenorrhea and confirmed diagnosis of endometriosis looking for the insertion of an LNG-IUS. At that day they will invite and allocated at random (through a computer generated system with opaque and sealed envelopes) to the LNG-IUS or the ENG-implant. At enrolment we will insert an LNG-IUS or an ENG-implant and at the same day we will assess the pain through a visual analogue scale (VAS) and we will apply the psychological general well being index questionnaire (PGWBI). It will delivery a menstrual calendar and a VAS form to register the events. The follow-up will be every 30 days (± 3 days) in which we will assess the the VAS form and the mesntrual calendars and we willd deliver a new one for the next 30 days. The study will end at 180 days after enrolment and at that last evaluation we will re-apply the PGWBI. Statistical analysis: Student-t test will be apply for the continued variavles with normal distribution and the variables without normal distribution will be evaluated through the Mann-Whitney test. Analysis of variance (ANOVA) with repetitive measurements will be use for the numerical dependent variables. The comparison between groups will be assess trough the Mann-Whitney test and according to intention to treat technique. (AU)