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Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

NCT01968317 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-09-14

Study results available
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Summary

The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.

Conditions

  • Endometrial Atypical Hyperplasia
  • Endometrial Adenocarcinoma

Interventions

DRUG

Megestrol acetate and metformin

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.

DRUG

Megestrol acetate

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Shanghai Changning Maternity & Infant Health Hospital

    collaborator OTHER

  • Xiaojun Chen

    lead OTHER

Principal Investigators

  • Xiaojun Chen, PhD · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • China

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 NCT01968317 on ClinicalTrials.gov