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Intrauterine Levonorgestrel and Observation or Observation Alone in Preventing Atypical Endometrial Hyperplasia and Endometrial Cancer in Women With Hereditary Non-Polyposis Colorectal Cancer or Lynch Syndrome

NCT00566644 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-07-10

No results posted yet for this study

Summary

RATIONALE: The use of intrauterine levonorgestrel may prevent atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome. It is not yet known whether intrauterine levonorgestrel and observation are more effective than observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.

PURPOSE: This randomized phase III trial is studying intrauterine levonorgestrel and observation to see how well they work compared with observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.

Conditions

Interventions

DEVICE

levonorgestrel-releasing intrauterine system

OTHER

questionnaire administration

PROCEDURE

observation

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Shirley Hodgson, MD · St George's, University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-10-31
Completion
2009-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566644 on ClinicalTrials.gov