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RECRUITINGPHASE2/PHASE3

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

NCT03463252•West China Second University Hospital

View on ClinicalTrials.gov

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

Age

0 - 40 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•For Patients With Endometrial Cancer：
•≤40 years of age:
•Having a strong desire for fertility preservation;
•Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;
•Disease limited to the endometrium (stage 1A) on MRI;
•Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);
•Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.
•≤ 40 years of age
•Having a strong desire for fertility preservation
•Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
+1 more criteria

Exclusion Criteria

•Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;
•Patients have lynch syndrome (LS);
•Patients have contraindications for pregnancy;
•Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);
•Patients refuse to participate in clinical follow-up or sign the informed consent form.
•For Patients With Endometrial atypical hyperplasia：
•Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
•Patients have contraindications for pregnancy
•Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
•Patients refuse to participate in clinical follow-up or sign the informed consent form.

Locations (1)

West China Second University Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

April 1, 2018

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2030

Last Updated

September 13, 2021

Enrollment

224

ESTIMATED participants

Conditions

Endometrial CancerAtypical Endometrial Hyperplasia

Interventions

Progesterone

DRUG

Mirena®

DEVICE

GnRH agonist

DRUG

Contacts

ZHENG Ying, Professor

CONTACT

+8613018256012 935398163@qq.com

CHEN Si Jing, postgraduate

CONTACT

+86218380361314 Zhy_chd@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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