Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Running, not enrolling · Phase 2
Conditions studied: Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
In brief
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.
Key facts
- Study ID
- NCT00788671
- Run by
- M.D. Anderson Cancer Center
- People needed
- 69
- Starts
- 2008-11-03
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2025-08-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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)
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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