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

NCT01234818 | Unknown Phase 2

• 1 other identifier: KGOG 2006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Hyperplasia

Keywords

Endometrial hyperplasia; LNG-IUS

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after LNG-IUS insertion

Secondary Outcomes (1)

• 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

Study Arms (1)

LNG-IUS, endometrial hyperplasia

EXPERIMENTAL

Device: Mirena (LNG-IUS)

Interventions

Mirena (LNG-IUS) DEVICE

* 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.

Also known as: Mirena

LNG-IUS, endometrial hyperplasia

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are histological confirmed as endometrial hyperplasia
• Patients who don't want hysterectomy
• Patients signed the written informed consent voluntarily

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Gynecologic Oncology Group: lead

Study Sites (1)

Gangnam CAH medical center

Seoul, Gangnamgu, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 26905333 DERIVED

MeSH Terms

Conditions

Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Seok Ju Seong, MD

  Ganganm CHA medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

KR (1)