Status:
COMPLETED
Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
Lead Sponsor:
Fudan University
Conditions:
Atypical Endometrial Hyperplasia
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 or LNG-IUS alo...
Detailed Description
After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipi...
Eligibility Criteria
Inclusion
- Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon hysteroscopy
- 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 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 :
180 Patients enrolled
Trial Details
Trial ID
NCT03241888
Start Date
July 4 2017
End Date
June 18 2020
Last Update
September 26 2024
Active Locations (1)
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1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200011