Status:
COMPLETED
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
Lead Sponsor:
Fudan University
Conditions:
Endometrial Neoplasm Malignant Stage I
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patie...
Detailed Description
After diagnosed of endometrioid endometrial cancer (EEC) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid...
Eligibility Criteria
Inclusion
- Primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy
- MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
- Have a desire for remaining reproductive function or uterus
- Need to be able to undergo correlative treatment and follow-up
Exclusion
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- Pregnancy or suspicion of pregnancy
- Have a history of EAH or EC and have disease relapse during Merina insertion
- Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Confirmed diagnosis of malignant tumor in genital system
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Hypersensitivity or contradiction to any component of this product
- Ask for removal of the uterus or other conservative treatment
- Smoker(\>15 cigarettes a day)
Key Trial Info
Start Date :
July 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03241914
Start Date
July 4 2017
End Date
June 18 2020
Last Update
November 20 2020
Active Locations (1)
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1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200011