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Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia

NCT05172999 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-13

No results posted yet for this study

Summary

To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.

Conditions

  • Atypical Endometrial Hyperplasia
  • Obesity
  • Fertility Issues

Interventions

DEVICE

levonorgestrel-releasing intrauterine system

Enrolled patients will be inserted this device for treating AEH to preserve fertility for 3-6 months or longer till complete response or operation if treatment fails, and the device may be removed if treatment changes.

DRUG

Polyethylene Glycol Loxenatide

Initiate injection of Loxenatide will be 0.1mg per week, if the patient can tolerate, the dose will be increased to 0.2mg per week, or else 0.1mg per week will be injected and the injection will last for no more than 28 weeks. If the patient cannot tolerate the least 0.1mg/week, she must be excluded from this trial.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • XIAOJUN CHEN, PhD · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-08
Primary Completion
2025-12-30
Completion
2026-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172999 on ClinicalTrials.gov