Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia

NCT00503581 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-11-03

Study results available
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Summary

This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.

Conditions

  • High Grade Squamous Intraepithelial Neoplasia
  • Stage 0 Uterine Corpus Cancer

Interventions

PROCEDURE

Biopsy

Undergo biopsy

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Megestrol Acetate

given orally

OTHER

Pharmacological Study

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Therapeutic Conventional Surgery

undergo hysterectomy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Michael Method · Gynecologic Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-07-31

Countries

  • United States

Study Locations

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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 NCT00503581 on ClinicalTrials.gov