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

Women with endometriosis-associated pain presented significant improvement in pelvic pain, dysmenorrhea, and quality of life with both an ENG implant and a levonorgestrel-releasing intrauterine system.

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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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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

1 Comments

Go to the profile of Rizki Amalia Wahyudi
Rizki Amalia Wahyudi 5 months ago

Good evening,

I'm rizki an obstrician student in indonesia. Do you mind if i ask you some quetion ?

1. Why you choose Non inferiority RCT for your methode?

2. How the affect size of this 2 variable?

3. Did you stiill follow up the patients until 3 years ahead? did it reported?

it's an honor for me if you are willing to answer my questions.

Thank you.