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

November 8, 2012 updated by: Korean Gynecologic Oncology Group

Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Mirena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 12 months after LNG-IUS insertion

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.
12 months after LNG-IUS insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
3,6,9,12 months after LNG-IUS insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Gynecologic Oncology Group

Investigators

  • Principal Investigator: Seok Ju Seong, MD, Ganganm CHA medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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