| Autor: |
Leipold G; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary., Tóth R; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary., Hársfalvi P; BiTrial Clinical Research, 1121 Budapest, Hungary., Lőczi L; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary.; Workgroup of Research Management, Doctoral School, Semmelweis University, 1085 Budapest, Hungary., Török M; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary.; Workgroup of Research Management, Doctoral School, Semmelweis University, 1085 Budapest, Hungary., Keszthelyi A; Department of Urology, Semmelweis University, 1082 Budapest, Hungary., Ács N; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary., Lintner B; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary., Várbíró S; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary.; Workgroup of Research Management, Doctoral School, Semmelweis University, 1085 Budapest, Hungary.; Department of Obstetrics and Gynecology, University of Szeged, 6725 Szeged, Hungary., Keszthelyi M; Department of Obstetrics and Gynecology, Semmelweis University, 1082 Budapest, Hungary. |
| Abstrakt: |
Endometrial cancer is a leading gynecological malignancy, with obesity being a significant risk factor due to increased estrogen production in body fat. Current treatments often involve hysterectomy, which precludes fertility, thus highlighting the need for fertility-preserving options. This study aims to evaluate the combined efficacy of a levonorgestrel intrauterine device (LNG-IUD), metformin, and liraglutide for treating women with endometrial hyperplasia or early stage endometrial cancer while preserving fertility. The study will enroll 264 women aged 18-45 with a BMI > 30 who desire uterine preservation. Participants will be randomized into three groups: LNG-IUD alone, LNG-IUD plus metformin, and LNG-IUD plus metformin and liraglutide. Primary outcomes will include complete pathological remission, while secondary outcomes will assess histological changes, glucose, insulin levels, and weight changes over a 12-month period. This study protocol hypothesizes that LNG-IUD combined with metformin and liraglutide may potentially lead to higher regression rates of endometrial hyperplasia (EH) and early stage endometrial cancer (EC) compared to LNG-IUD alone. Furthermore, the protocol anticipates that these combination therapies will demonstrate good tolerability with minimal adverse effects, suggesting the potential benefit of integrating metabolic interventions with LNG-IUD to enhance treatment efficacy while preserving fertility in women with EH and EC. |
