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A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
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.
PRIMARY OBJECTIVES: I. To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC). II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy. SECONDARY OBJECTIVES: I. To assess quality of life outcomes in patients treated with levonorgestrel IUD. II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer. III. To evaluate the molecular profile of the hysterectomy specimen of patients treated with the levonorgestrel IUD. Compare molecular profile in pretreatment tissue to hysterectomy tissue between responders and non-responders to levonorgestrel IUD therapy. IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD. OUTLINE: Patients undergo placement of a levonorgestrel-releasing intrauterine system. After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson League City
Nassau Bay, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
MD Anderson in The Woodlands
The Woodlands, Texas, United States
Start Date
November 3, 2008
Primary Completion Date
June 10, 2016
Completion Date
November 30, 2027
Last Updated
August 15, 2025
69
ACTUAL participants
Laboratory Biomarker Analysis
OTHER
Levonorgestrel-Releasing Intrauterine System
DEVICE
Quality-of-Life Assessment
OTHER
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05334069
NCT03463252
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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