Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006 (KGOG2006)
Primary Purpose
Endometrial Hyperplasia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirena (LNG-IUS)
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Endometrial hyperplasia, LNG-IUS
Eligibility Criteria
Inclusion Criteria:
- Patients who are histological confirmed as endometrial hyperplasia
- Patients who don't want hysterectomy
- Patients signed the written informed consent voluntarily
Exclusion Criteria:
- 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
Sites / Locations
- Gangnam CAH medical centerRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LNG-IUS, endometrial hyperplasia
Arm Description
Outcomes
Primary Outcome Measures
response rate
LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients with LNG-IUS inside in uterus.
At the first year of LNG-IUS insertion, D&C is performed under anesthesia after the endometrial aspiration biopsy with LNG-IUS inside in uterus and the biopsy findings are compared. If the office endometrial aspiration biopsy shows exacerbation, treatment with LNG-IUS must be stopped and other specific treatment should be initiated.
Secondary Outcome Measures
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Full Information
NCT ID
NCT01234818
First Posted
November 3, 2010
Last Updated
November 8, 2012
Sponsor
Korean Gynecologic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT01234818
Brief Title
Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
Acronym
KGOG2006
Official Title
Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korean Gynecologic Oncology Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 LNG-IUS is known as an alternative of oral progesterone agents without incurring the disadvantages of oral progestogens. Therefore, it is hypothesized that if the therapeutic efficacy of LNG-IUS is similar or above oral progesterone, LNG-IUS would be a standard treatment for the EH patients who don't want hysterectomy. LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
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-IUS is placed in uterus.
ENDPOINTS The primary endpoints of this study is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW This study is a single arm, prospective multi-institutional study. Its protocol was approved by the Institutional Review Board of each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD Patient Selection and Enrollment: 12month after IRB approval of clinical trial Institution.
TREATMENT METHODS LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients with LNG-IUS inside in uterus.
At the first year of LNG-IUS insertion, D&C is performed under anesthesia after the endometrial aspiration biopsy with LNG-IUS inside in uterus and the biopsy findings are compared. If the office endometrial aspiration biopsy shows exacerbation, treatment with LNG-IUS must be stopped and other specific treatment should be initiated.
INVESTIGATIONAL PRODUCT
General Name/Brand name: Mirena - Bayer ② Active ingredient: levonorgestrel 52mg ③ Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
PLANNED NUMBER OF SUBJECT 80 patients with biopsy proven endometrial hyperplasia (54 patients without atypical hyperplasia, 26 patients with atypical hyperplasia) STATISTICAL CONSIDERATIONS The primary objective of this study is to estimate the treatment efficacy of the LNG-IUS in endometrial hyperplasia patients with respect to the response rate. We expect different response rate depending on the atypia status. The atypia status will be determined by the office endometrial aspiration biopsy which will be performed before and three months after the LNG-IUS. The expected response rate would be 70% for those with Atypia,, and 85% for those without Atypia. Different estimation approach will be used depending on the Atypia status. For those without Atypia, the response rate will be estimated with margin of error of 10%. The sample size needed for this estimation would be 54 patients after considering 10% of follow-up loss. For those with atypia, we will compare with the historical control where the expected response rate would be 40%. The sample size needed for the comparison, a total of 26 patients will be needed after consideration of 90% power, 5% one-sided test type I error, and 10% follow-up loss. The response rate with 95% confidence interval will be generated and the Z-test will be used for comparisons of the response rates.
The Secondary objective is to estimate the consistency of the office endometrial aspiration biopsy and D&C. Kappa statistics will be used
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia
Keywords
Endometrial hyperplasia, LNG-IUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LNG-IUS, endometrial hyperplasia
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mirena (LNG-IUS)
Other Intervention Name(s)
Mirena
Intervention Description
General Name/Brand name: Mirena - Bayer ② Active ingredient: levonorgestrel 52mg ③ Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
Primary Outcome Measure Information:
Title
response rate
Description
LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients with LNG-IUS inside in uterus.
At the first year of LNG-IUS insertion, D&C is performed under anesthesia after the endometrial aspiration biopsy with LNG-IUS inside in uterus and the biopsy findings are compared. If the office endometrial aspiration biopsy shows exacerbation, treatment with LNG-IUS must be stopped and other specific treatment should be initiated.
Time Frame
12 months after LNG-IUS insertion
Secondary Outcome Measure Information:
Title
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are histological confirmed as endometrial hyperplasia
Patients who don't want hysterectomy
Patients signed the written informed consent voluntarily
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok Ju Seong, MD
Organizational Affiliation
Ganganm CHA medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam CAH medical center
City
Seoul
State/Province
Gangnamgu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Ju Seong
Email
sjseongcheil@yahoo.co.kr
12. IPD Sharing Statement
Citations:
PubMed Identifier
26905333
Citation
Kim MK, Seong SJ, Kim JW, Jeon S, Choi HS, Lee IH, Lee JH, Ju W, Song ES, Park H, Ryu HS, Lee C, Kang SB. Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System: A Korean Gynecologic-Oncology Group Study. Int J Gynecol Cancer. 2016 May;26(4):711-5. doi: 10.1097/IGC.0000000000000669.
Results Reference
derived
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Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
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