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Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer

NCT00788671 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-08-15

Study results available
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Summary

This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.

Conditions

  • Atypical Endometrial Hyperplasia
  • Stage I Uterine Corpus Cancer AJCC v7
  • Stage IA Uterine Corpus Cancer AJCC v7
  • Stage IB Uterine Corpus Cancer AJCC v7
  • Stage II Uterine Corpus Cancer AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DEVICE

Levonorgestrel-Releasing Intrauterine System

Undergo placement of a levonorgestrel-releasing intrauterine system

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Shannon N Westin · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-03
Primary Completion
2016-06-10
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT00788671 on ClinicalTrials.gov