NCT03618472

Brief Summary

Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

December 3, 2024

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

August 1, 2018

Last Update Submit

November 28, 2024

Conditions

MetforminCA Endometrium

Outcome Measures

Primary Outcomes (1)

  • Change of Ki-67 expression in endometrial tumor

    metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.

    4 weeks

Secondary Outcomes (1)

  • Change of grade in endometrial tumor

    4 weeks

Study Arms (2)

metformin

EXPERIMENTAL

The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy

Drug: Metformin Hydrochloride 850 MG

placebo

PLACEBO COMPARATOR

The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy

Drug: Placebo Oral Tablet

Interventions

Metformin Hydrochloride 850 MGDRUG

Regular strength metformin (850 mg/tab)

Also known as: if any
metformin
Placebo Oral TabletDRUG

Starch based placebo manufatured to mimic Metformin 850 mg

Also known as: if any
placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study

You may not qualify if:

  • Women without diabetes type 1 and 2
  • Women who have allergy Biguanide
  • Women who have hypoglycemic medication
  • Women who have GFR \<45 ml/min/1.73 m2
  • Women who have evidence of stage 3 or 4 of endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 7, 2018

Study Start

July 1, 2018

Primary Completion

November 30, 2019

Study Completion

January 30, 2020

Last Updated

December 3, 2024

Record last verified: 2018-10

Locations

TH(1)