Clinical trial · Interventional
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
- 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)
This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Stage IA Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Uterine Corpus Cancer AJCC v7 | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Levonorgestrel-Releasing Intrauterine System | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (levonorgestrel-releasing intrauterine system)
- description
- Patients undergo placement of a levonorgestrel-releasing intrauterine system.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Device: Levonorgestrel-Releasing Intrauterine System
- Other: Quality-of-Life Assessment
Primary outcomes (2)
- measure
- Response Rate at 12 Month
- timeFrame
- At 1 year
- description
- Will be defined as complete response or partial response based on the endometrial biopsy.
- measure
- Efficacy of the Levonorgestrel Intrauterine Device (IUD)
- timeFrame
- At 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1)desire for future fertility 2)morbid obesity (body mass index \> 40) 3)multiple co-morbidities (ASA Class 3 or 4) * No prior treatment for diagnoses in inclusion criteria 1. * Women of any racial or ethnic group. * Ability to comply with endometrial biopsies every 3 months. * Willing and able to sign informed consent. * Age greater than 18 years. Exclusion Criteria: * Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1. * Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen. * Evidence of extrauterine spread of disease on imaging or during surgical evaluation. * Congenital or acquired uterine anomaly which distorts the uterine cavity. * Acute pelvic inflammatory disease. * Acute liver disease or previously diagnosed liver tumor (benign or malignant). * Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse. * Genital actinomycosis. * Current carcinoma of the breast. * Current pregnancy. * Breastfeeding mothers.
References
Publications (1)
- DERIVEDWestin SN, Fellman B, Sun CC, Broaddus RR, Woodall ML, Pal N, Urbauer DL, Ramondetta LM, Schmeler KM, Soliman PT, Fleming ND, Burzawa JK, Nick AM, Milbourne AM, Yuan Y, Lu KH, Bodurka DC, Coleman RL, Yates MS. Prospective phase II trial of levonorgestrel intrauterine device: nonsurgical approach for complex atypical hyperplasia and early-stage endometrial cancer. Am J Obstet Gynecol. 2021 Feb;224(2):191.e1-191.e15. doi: 10.1016/j.ajog.2020.08.032. Epub 2020 Aug 15. PMID 32805208