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Fertil Steril. 2018 Nov;110(6):1129-1136. doi: 10.1016/j.fertnstert.2018.07.003.

Control of endometriosis-associated pain with etonogestrel-releasing contraceptive implant and 52-mg levonorgestrel-releasing intrauterine system: randomized clinical trial.

Author information

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.

KEYWORDS:

Endometriosis; etonogestrel-releasing contraceptive implant; levonorgestrel-releasing intrauterine system; pelvic pain

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