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NCT00161226 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by University of Medicine and Dentistry of New Jersey.
- Terminated
- Registry status
- 44
- Enrollment target
NCT00161226: Clinical Trial study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT00161226 is a clinical trial that was terminated before completion, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00161226 was terminated before completion, sponsored by University of Medicine and Dentistry of New Jersey.
- TERMINATED
- Registry status
- 44 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Levonorgestrel intrauterine system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2004-02 |
| Est. Completion | 2006-06 |
Why NCT00161226 stopped before completion
NCT00161226 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel intrauterine system is the first listed.
NCT00161226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00161226 about?
NCT00161226 is a clinical study titled "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 wan...
What is the current status of trial NCT00161226?
This trial is currently terminated. The enrollment target is 44 participants. The study started on 2004-02. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00161226?
The interventions under investigation include: Levonorgestrel intrauterine system (DEVICE).
Who is sponsoring clinical trial NCT00161226?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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