Status:
ACTIVE_NOT_RECRUITING
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Atypical Endometrial Hyperplasia
Stage I Uterine Corpus Cancer AJCC v7
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ca...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00788671
Start Date
November 3 2008
End Date
November 30 2027
Last Update
August 15 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
3
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
4
MD Anderson in Katy
Houston, Texas, United States, 77094