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Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006

This study is currently recruiting participants.
Verified November 2012 by Korean Gynecologic Oncology Group
Sponsor:
Information provided by (Responsible Party):
Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01234818
First received: November 3, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Endometrial Hyperplasia
 Device: Mirena (LNG-IUS)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korean Gynecologic Oncology Group:

Primary Outcome Measures:
  • response rate [ Time Frame: 12 months after LNG-IUS insertion ] [ Designated as safety issue: No ]

    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. [ Time Frame: 3,6,9,12 months after LNG-IUS insertion ] [ Designated as safety issue: No ]
    consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.


Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG-IUS, endometrial hyperplasia Device: Mirena (LNG-IUS)
  • 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.
Other Name: Mirena

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234818

Locations
Korea, Republic of
Gangnam CAH medical center Recruiting
Seoul, Gangnamgu, Korea, Republic of
Contact: Seok Ju Seong         sjseongcheil@yahoo.co.kr    
Sponsors and Collaborators
Korean Gynecologic Oncology Group
Investigators
Principal Investigator: Seok Ju Seong, MD Ganganm CHA medical center
  More Information

No publications provided

Responsible Party: Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01234818     History of Changes
Other Study ID Numbers: KGOG 2006
Study First Received: November 3, 2010
Last Updated: November 8, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Gynecologic Oncology Group:
Endometrial hyperplasia
LNG-IUS

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Adenoma
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 19, 2013