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Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

Endometrial Hyperplasia Clinical Trial

Official title:
Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia: A Non-Inferiority Study

Clinical Trial Summary

The purpose of this research study is to compare the uterus tissue of women who receive an intrauterine system to treat their endometrial hyperplasia with the uterine tissue of women who receive megestrol acetate to treat their hyperplasia. While both methods are commonly used in practice, investigators would like to see what effects each treatment has on uterine tissue.

Clinical Trial Description

Primary Objective: To determine if Levonorgestrel-releasing intrauterine system is of equal efficacy to the standard systemic progestin therapy (megestrol acetate) based on endometrial sampling at 6 months after randomization. Non-inferiority analysis. Secondary Objective(s): - To determine the safety of each treatment modality. - Determine the feasibility of transvaginal ultrasound to predict treatment response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04897217
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Withdrawn
Phase Phase 3
Start date June 30, 2023
Completion date November 2026
View Details
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