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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01234818 |
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Date of registration:
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03/11/2010 |
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Primary sponsor: |
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Public title:
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Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
KGOG2006 |
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Scientific title:
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Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006) |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01234818 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seok Ju Seong |
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Address:
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Telephone:
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Email:
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sjseongcheil@yahoo.co.kr |
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Affiliation:
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Name:
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Seok Ju Seong, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ganganm CHA medical center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients who are histological confirmed as endometrial hyperplasia
2. Patients who don't want hysterectomy
3. Patients signed the written informed consent voluntarily
Exclusion Criteria:
1. Pregnancy or suspicion of pregnancy
2. Under treatment of metastatic cancer from other organs or less than 5 years after
previous cancer therapy
3. Congenital or acquired uterine anomaly including fibroids if they distort the uterine
cavity
4. Genital (vaginal, uterine or ovarian) infection
5. Acute liver disease or liver tumor (benign or malignant)
6. Thrombosis or phlebothrombosis requiring treatment
7. Acute severe disease of arteries such as stroke or heart infarction or a history of
artery disease
8. Hypersensitivity to any component of this product
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometrial Hyperplasia
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Intervention(s)
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Device: Mirena (LNG-IUS)
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Primary Outcome(s)
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response rate
[Time Frame: 12 months after LNG-IUS insertion]
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Secondary Outcome(s)
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consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
[Time Frame: 3,6,9,12 months after LNG-IUS insertion]
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Secondary ID(s)
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KGOG 2006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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