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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
MPA oral 250mg-500mg qd for 3 months per cycle
levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle
West China Second University Hospital
Chengdu, Sichuan, China
RECRUITINGPathologic Response
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: 6-12 months
Pregnancy Rate
The percentage of successful pregnancies in the CR patients.
Time frame: 7-144 months
Live Birth Rate
The percentage of successfully alive baby delivery in the pregnant patients.
Time frame: 16-144 months
Side-Affects Rate
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.
Time frame: 1-144 months
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