CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Megestrol acetate and metformin +1 moredrug
Likely dose
Megestrol acetate and metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01968317
NCT01968317Phase 2Completed
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Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

Xiaojun Chen·interventional·Posted Oct 24, 2013·Updated Sep 14, 2021

In Brief

A Phase 2 clinical trial evaluating Megestrol acetate and metformin and Megestrol acetate for Endometrial Atypical Hyperplasia and Endometrial Adenocarcinoma. Completed, enrolled 150 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Atypical Hyperplasia, Endometrial Adenocarcinoma
CountriesChina
CollaboratorsFudan University, Shanghai 6th People's Hospital, Zhejiang Cancer Hospital, Shanghai Changning Maternity & Infant Health Hospital

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 24, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.7 years ago

Interventions

Megestrol acetate and metformindrug

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

Megestrol acetatedrug

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