This phase III clinical trial compares a levonorgestrel-releasing intrauterine system (LNG-IUS) to megestrol acetate for the treatment of atypical endometrial hyperplasia. The LNG-IUS secretes progestin locally on the endometrium to suppress endometrial growth, while megestrol acetate is an oral, systemic form of progestin. This study is being done to see whether LNG-US works the same as megestrol acetate in treating patients with atypical endometrial hyperplasia.
Additional locations may be listed on ClinicalTrials.gov for NCT04897217.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine if LNG-IUS is of equal efficacy to the systemic progestin therapy (megestrol acetate) based on endometrial sampling at 6 months after randomization.
SECONDARY OBJECTIVES:
I. To determine the safety of each treatment modality.
II. Determine the feasibility of transvaginal ultrasound to predict treatment response.
III. Determine tolerability and compliance of medication or intrauterine device (IUD).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive megestrol acetate orally (PO) daily (QD) beginning day 1 and undergo biopsy of the uterus at 3 and 6 months.
ARM II: Patients undergo implantation of a levonorgestrel-releasing intrauterine device on day 1 and undergo biopsy of the uterus at 3 and 6 months.
After completion of study treatment, patients are followed at 30 days.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorJanelle Darby
