Clinical trial · Interventional
Management of Endometrial Hyperplasia With a LNG-IUS: Multicenter Study: KGOG2006
Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirena (LNG-IUS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LNG-IUS, endometrial hyperplasia
- interventionNames
- Device: Mirena (LNG-IUS)
Primary outcomes (1)
- measure
- response rate
- timeFrame
- 12 months after LNG-IUS insertion
- 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.
Secondary outcomes (1)
- measure
- consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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