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Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer

NCT01943058 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-09-10

No results posted yet for this study

Summary

This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.

Conditions

  • Atypical Endometrial Hyperplasia
  • Endometrial Adenocarcinoma
  • Recurrent Endometrial Carcinoma
  • Stage IA Endometrial Carcinoma
  • Stage IB Endometrial Carcinoma
  • Stage II Endometrial Carcinoma
  • Stage IIIA Endometrial Carcinoma
  • Stage IIIB Endometrial Carcinoma
  • Stage IIIC Endometrial Carcinoma
  • Stage IVA Endometrial Carcinoma
  • Stage IVB Endometrial Carcinoma

Interventions

DRUG

megestrol acetate

Given PO

DEVICE

levonorgestrel-releasing intrauterine system

Given IUD

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

questionnaire administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Yvonne Lin-Liu · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-10-31
Completion
2017-10-31

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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 NCT01943058 on ClinicalTrials.gov