CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0094 (clinicaltrials.gov NCT No: NCT00788671)
Title:A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
Principal Investigator:Shannon Westin
Treatment Agent:Levonorgestrel IUD
Study Status:Open
Study Description:The goal of this clinical research study is to learn the level of effectiveness
of the Mirena intrauterine device (levonorgestrel IUD) in treating hyperplasia
of the lining of the uterus and/or early-stage cancer of the lining of the
uterus. Researchers want to learn if the levonorgestrel IUD can help to shrink
or slow the growth of the disease.

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Disease Group:Endometrial
Phase of Study:Phase II
Treatment Agents:Levonorgestrel IUD
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Typically, there will be no hospitalization associated with the pre-treatment
surgery or LIUD treatment.
Supported By:50 CA098258 - 05 - Westin (PI)9/07-8/08
Return Visit:Patients must come to MDACC or the affiliated hospital every three months for a
total of one year.
Home Care:None.


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Physician Name:Shannon Westin
Dept:Gynecologic Oncology
For Clinical Trial Enrollment:713-745-3358
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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