Brief 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
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
Brief Summary
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.
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.
Study Type
Observational
Condition
Endometrial Cancer
Intervention
Levonorgestrel intrauterine system
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
44
Start Date
February 2004
Completion Date
June 2006
Primary Completion Date
June 2006
Eligibility 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
Gender
Female
Ages
35 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Allison Wagreich, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00161226
Organization ID
4800
Secondary IDs
CINJ#100401
Study Sponsor
University of Medicine and Dentistry of New Jersey
Study Sponsor
Allison Wagreich, MD, Principal Investigator, Rutgers, The State University of New Jersey
Verification Date
December 2009