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.

Study Overview

• Status: Terminated
• Conditions: Endometrial Cancer
• Intervention / Treatment: Device: Levonorgestrel intrauterine system

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
• Enrollment (Anticipated): 44

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Institute Of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Levonorgestrel IUD, Prevention of Endometrial Cancer, Patients Aged 35-50, BMI > 30

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Investigators: Principal Investigator: Allison Wagreich, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): December 11, 2009
• Last Update Submitted That Met QC Criteria: December 10, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: endometrial cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 4800; CINJ#100401