RecruitingPhase 2Phase 3NCT03463252

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

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma


Sponsor

West China Second University Hospital

Enrollment

224 participants

Start Date

Apr 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a hormone-releasing IUD (LNG-IUS, like a Mirena device) can be used as a fertility-preserving treatment for young women with early-stage uterine (endometrial) cancer or abnormal uterine cell growth (endometrial atypical hyperplasia), instead of surgery that would prevent future pregnancy. **You may be eligible if...** - You are 40 years old or younger - You strongly wish to preserve your fertility - You have been diagnosed with either: - Early-stage, low-grade endometrial cancer (Grade 1, confined to the uterine lining, progesterone receptor positive), OR - Atypical endometrial hyperplasia (pre-cancerous uterine cell changes) - For endometrial cancer: your CA125/199 tumor markers are normal and MRI shows no spread outside the uterus **You may NOT be eligible if...** - You have allergies or contraindications to the drugs used - You have Lynch syndrome (a hereditary cancer condition) - You have reasons you cannot become pregnant - You have a serious infection in the genital tract or a uterine abnormality that prevents IUD placement - You refuse to attend follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProgesterone

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

DEVICEMirena®

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

DRUGGnRH agonist

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


Locations(1)

West China Second University Hospital

Chengdu, Sichuan, China

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NCT03463252


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