Volume 110, Issue 6, Pages 1129–1136

Authors:

Nelsilene Carvalho, M.D., Ph.D., Deborah Margatho, M.D., Kleber Cursino, M.D., Ph.D., Cristina L. Benetti-Pinto, M.D., Ph.D., Luis Bahamondes, M.D., Ph.D.

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.

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