Status:
UNKNOWN
Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
Lead Sponsor:
Korean Gynecologic Oncology Group
Conditions:
Endometrial Hyperplasia
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) in endometrial hyperplasia (EH) patients. The ...
Detailed Description
PURPOSE This prospective study aims to analyze the treatment efficacy of LNG-IUS in endometrial hyperplasia patients and to analyze the accuracy of office endometrial aspiration biopsy during the LNG-...
Eligibility Criteria
Inclusion
- Patients who are histological confirmed as endometrial hyperplasia
- Patients who don't want hysterectomy
- Patients signed the written informed consent voluntarily
Exclusion
- Pregnancy or suspicion of pregnancy
- Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Genital (vaginal, uterine or ovarian) infection
- Acute liver disease or liver tumor (benign or malignant)
- Thrombosis or phlebothrombosis requiring treatment
- Acute severe disease of arteries such as stroke or heart infarction or a history of artery disease
- Hypersensitivity to any component of this product
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01234818
Start Date
November 1 2010
End Date
December 1 2012
Last Update
November 12 2012
Active Locations (1)
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1
Gangnam CAH medical center
Seoul, Gangnamgu, South Korea