Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplas… (NCT00788671) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
United States69 participantsStarted 2008-11-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 pre…
What they're measuring
1
Response Rate at 12 Month
Timeframe: At 1 year
2
Efficacy of the Levonorgestrel Intrauterine Device (IUD)