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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
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, September 2005
Sponsored by: University of Medicine and Dentistry New Jersey
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00161226
  Purpose

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

MedlinePlus related topics: Cancer
Drug Information available for: Levonorgestrel
U.S. FDA Resources
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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Estimated Enrollment: 44
Study Start Date: April 2004
Estimated Study Completion Date: April 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161226

Contacts
Contact: Allison Wagreich, MD 732-235-7258 wagreial@umdnj.edu

Locations
United States, New Jersey
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Gail Williams, RN     732-235-9835        
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Allison Wagreich, MD University of Medicine and Dentistry New Jersey
  More Information

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

Keywords provided by University of Medicine and Dentistry New Jersey:
endometrial cancer

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Levonorgestrel
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009