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Sponsored by: |
University of Medicine and Dentistry New Jersey |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00161226 |
Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates. Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will be randomized to either observation or treatment. The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women will have endometrial biopsies and blood work at the beginning and end of the study. All of the women will have an ultrasound at the beginning of the study. The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent. The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer. A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Device: Levonorgestrel intrauterine system |
Phase II |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35 |
Estimated Enrollment: | 44 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2009 |
Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates. Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will be randomized to either observation or treatment. The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women will have endometrial biopsies and blood work at the beginning and end of the study. All of the women will have an ultrasound at the beginning of the study. The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent. The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer. A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.
Ages Eligible for Study: | 40 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Woman between 40-50 years of age. Body mass index (BMI) ³ 35. Benign (no hyperplasia or cancer) endometrial biopsy prior to randomization Has an intact uterus
Exclusion:
Present infection with gonorrhea or chlamydia or within the last 5 years. Bacterial vaginosis that does not respond to one course of antibiotics. History of pelvic inflammatory disease in the last 5 years. Patients who are pregnant or who desire to become pregnant Does not desire fertility History of deep venous thrombosis or pulmonary embolus
Contact: Allison Wagreich, MD | 732-235-7258 | wagreial@umdnj.edu |
United States, New Jersey | |
Cancer Institute of New Jersey | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Gail Williams, RN 732-235-9835 |
Principal Investigator: | Allison Wagreich, MD | University of Medicine and Dentistry New Jersey |
Study ID Numbers: | 4800, CINJ#100401 |
Study First Received: | September 8, 2005 |
Last Updated: | April 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00161226 |
Health Authority: | United States: Institutional Review Board |
endometrial cancer |
Genital Diseases, Female Endometrial Neoplasms Levonorgestrel Genital Neoplasms, Female |
Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Endometrial cancer |
Neoplasms Neoplasms by Site Contraceptive Agents Therapeutic Uses Contraceptives, Oral |
Physiological Effects of Drugs Contraceptive Agents, Female Contraceptives, Oral, Synthetic Reproductive Control Agents Pharmacologic Actions |