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Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

NCT03463252 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2021-09-13

No results posted yet for this study

Summary

Primary end points:

This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.

Second end points:

To analyze the appearances of side-effects.

Conditions

Interventions

DRUG

Progesterone

MPA oral 250mg-500mg qd for 3 months per cycle

DEVICE

Mirena®

levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle

DRUG

GnRH agonist

GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle

Sponsors & Collaborators

  • West China Second University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2025-12-30
Completion
2030-12-30

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 NCT03463252 on ClinicalTrials.gov