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
3 other identifiers
interventional
69
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2016
CompletedResults Posted
Study results publicly available
April 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
ExpectedAugust 15, 2025
August 1, 2025
7.6 years
November 10, 2008
January 12, 2022
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Response Rate at 12 Month
Will be defined as complete response or partial response based on the endometrial biopsy.
At 1 year
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
To determine the efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC), defined as complete regression disease. The primary efficacy endpoint was pathologic response rate (RR) at 12 months defined as complete response (CR) or partial response (PR). CR was defined as no evidence of cancer or hyperplasia with atypia in patients with (CAH) or EEC. PR was defined as CAH in patients with EEC. Progressive disease (PD) was defined as grade 2 endometrioid endometrial cancer or above in patients with EEC or the presence of any cancer in patients with CAH.
At 1 year
Secondary Outcomes (1)
Quality of Life Score Using the Short Form-36 (SF-36) Survey
At baseline, 3 month, 6 month, 9 month and 12 month
Study Arms (1)
Treatment (levonorgestrel-releasing intrauterine system)
EXPERIMENTALPatients undergo placement of a levonorgestrel-releasing intrauterine system.
Interventions
Correlative studies
Undergo placement of a levonorgestrel-releasing intrauterine system
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (7)
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
MD Anderson in Katy
Houston, Texas, 77094, United States
MD Anderson League City
Nassau Bay, Texas, 77058, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
Related Publications (1)
Westin 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: 32805208DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shannon N. Westin, MD, Associate Professor, Gyn Onc & Reproductive Med
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon N Westin
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
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 10, 2008
First Posted
November 11, 2008
Study Start
November 3, 2008
Primary Completion
June 10, 2016
Study Completion (Estimated)
November 30, 2027
Last Updated
August 15, 2025
Results First Posted
April 28, 2022
Record last verified: 2025-08