Nelsilene Carvalho1, Deborah Margatho1, Kleber Cursino1, Cristina L Benetti-Pinto1, Luis Bahamondes2. 1. Department of Obstetrics and Gynecology, Faculty of Medical Sciences, University of Campinas, Campinas, São Paolo, Brazil. 2. Department of Obstetrics and Gynecology, Faculty of Medical Sciences, University of Campinas, Campinas, São Paolo, Brazil. Electronic address: bahamond@caism.unicamp.br.
Abstract
OBJECTIVE: To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain. DESIGN: Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months. SETTING:University teaching hospital. PATIENT(S): One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools. INTERVENTION(S): The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle. MAIN OUTCOME MEASURE(S): Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar. RESULT(S): Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively. CONCLUSION(S): In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov under number NCT02480647.
RCT Entities:
OBJECTIVE: To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain. DESIGN: Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months. SETTING: University teaching hospital. PATIENT(S): One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools. INTERVENTION(S): The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle. MAIN OUTCOME MEASURE(S): Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar. RESULT(S): Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively. CONCLUSION(S): In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov under number NCT02480647.