Evaluation of the treatment of adenomyosis with Dienogest, Etonogestrel implant and levonorgestrel intrauterine device - randomized clinical trial

• Grant number: 23/16149-5
• Support Opportunities: Regular Research Grants
• Start date: March 01, 2024
• End date: February 28, 2026
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Daniela Angerame Yela Gomes
• Grantee: Daniela Angerame Yela Gomes
• Host 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

Abstract

Introduction: adenomyosis is a common type of endometriosis in which endometrial tissue proliferates in the muscular layer of the uterus, the myometrium. Symptoms are characterized by pelvic pain and abnormal uterine bleeding. It is essential to find ways to alleviate the symptoms that degrade the quality of life of these women. Among the treatment possibilities is the use of progestogens. There are few studies evaluating the comparison of the effectiveness of Dienogest and the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of adenomyosis and there are no studies with etonogestrel implant. Objective: to compare the effectiveness of LNG-IUS, etonogestrel implant and Dienogest in the treatment of women with adenomyosis. Subjects and methods: A randomized clinical trial will be carried out with 120 women with adenomyosis using dienogest (40 women), LNG-IUS (40 women) and etonogestrel implant (40 women) at the Menorrhagia Outpatient Clinic of the Tocogynecology Department of the Center of Comprehensive Attention to Women's Health (CAISM) at the State University of Campinas (UNICAMP). Abnormal uterine bleeding, fatigue, pain symptoms and uterine volume will be evaluated after 6 and 12 months of treatment with medications and their side effects as well as the women's sociodemographic characteristics. Data analysis: A form created especially for this study will be used, filled out using information contained in the medical records selected according to the inclusion and exclusion criteria. All forms will be carefully reviewed, coded and typed. For this study, a specific database will be created in Microsoft Excel®. The frequencies, means and standard deviation of the variables will be calculated. Fisher's Exact Test and the chi-square test will be used to compare qualitative variables, and analysis of variance (ANOVA) or Kruskal-Wallis test will be used to compare continuous variables. The P value will be considered significant when <0.05. To carry out these procedures, SAS version 9.4 will be used. (AU)