West China Second University Hospital
Chengdu, Sichuan, 610000, China
Location status: Recruiting
NCT Number: NCT03463252
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.
Interested in participating?
Request InfoUp to 40 year
Female
Interventional
Phase 2 / Phase 3
Chengdu, Sichuan, 610000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For Patients With Endometrial Cancer:
Inclusion criteria
Exclusion criteria
For Patients With Endometrial atypical hyperplasia:
Inclusion criteria
Exclusion criteria
MPA oral 250mg-500mg qd for 3 months per cycle
Other names: medroxyprogesterone acetate (MPA)
levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
Other names: LNG-IUS
GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle
Other names: GnRH-a
Time frame: 6-12 months
Pathologic response to medicine treatment is categorized as complete response (CR), partial response (PR), no change (NC), and progressive disease (PD). CR is defined as the absence of any hyperplastic or cancerous lesion. PR is defined as the residual lesion with degeneration and atrophy of endometrial glands. NC is defined as residual lesion without degeneration or atrophy of endometrial glands. PD is defined as the appearance of endometrial cancer for EAH and grade 2 (G2) or 3 for EC.
Time frame: 7-144 months
The percentage of successful pregnancies in the CR patients.
Time frame: 16-144 months
The percentage of successfully alive baby delivery in the pregnant patients.
Time frame: 1-144 months
The appearances of side-effects include weight gain, irregular vaginal bleeding, breast pain, appetite changes, nausea, vomiting, rash, jaundice, thromboembolism, hypertension, liver dysfunction, kidney dysfunction, glucose intolerance, and diabetes.
Contact information is provided by the study sponsor or research team.
CHEN Si Jing, postgraduate
CONTACT
ZHENG Ying, Professor
CONTACT
West China Second University Hospital
Other
Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07544680
Abnormal Uterine Bleeding (AUB), Atypical Endometrial Hyperplasia
Murfreesboro, Tennessee, United States
View Trial DetailsNCT05051722
Adnexal Diseases, Adnexal Mass
Phoenix, Arizona, United States
View Trial DetailsNCT07377734
Atypical Endometrial Hyperplasia, Endometrial Cancer
Beijing, China
View Trial DetailsNCT07714070
Atypical Endometrial Hyperplasia, Endometrial Cancer
Beijing, Beijing Municipality, China
View Trial Details