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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


Phase 2
35 Years
50 Years
Not Enrolling
Female
Endometrial Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Allison Wagreich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Institutional Review Board

Study ID:

4800

NCT ID:

NCT00161226

Start Date:

February 2004

Completion Date:

June 2006

Related Keywords:

  • Endometrial Cancer
  • endometrial cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Cancer Institute of New JerseyNew Brunswick, New Jersey  08901