Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01877564
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenocarcinoma of the Endometrium
Intervention Drug: Metformin
Enrollment 10
Recruitment Details Participants were recruited from the UAMS Gynecologic Oncology Clinic between August 2013 and July 2016.
Pre-assignment Details Subject eligibility was established before treatment randomization and included eligibility assessments, study assessments, lab tests, and pathology assessments.
Arm/Group Title Group 1 - Metformin Group 2 - No Treatment
Hide Arm/Group Description

oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin

no metformin for 14-21 days
Period Title: Overall Study
Started 6 4
Completed 6 4
Not Completed 0 0
Arm/Group Title Group 1 - Metformin Group 2 - No Treatment Total
Hide Arm/Group Description

oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin

no metformin for 14-21 days Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
4
 100.0%
8
  80.0%
>=65 years
2
  33.3%
0
   0.0%
2
  20.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 10 participants
60.6
(42 to 72)
61
(58 to 63)
60.8
(42 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
6
 100.0%
4
 100.0%
10
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
1
  10.0%
White
5
  83.3%
3
  75.0%
8
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  25.0%
1
  10.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 10 participants
6
 100.0%
4
 100.0%
10
 100.0%
1.Primary Outcome
Title IHC-based Tissue Markers of Proliferation
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title Group 1 - Metformin Group 2 - No Treatment
Hide Arm/Group Description:

oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin

no metformin for 14-21 days
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 - Metformin Group 2 - No Treatment
Hide Arm/Group Description

oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin

no metformin for 14-21 days
All-Cause Mortality
Group 1 - Metformin Group 2 - No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 - Metformin Group 2 - No Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 - Metformin Group 2 - No Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/4 (0.00%)    
Renal and urinary disorders     
dysuria  [1]  1/6 (16.67%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
painful urination
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Beth Scanlan
Organization: University of Arkansas for Medical Sciences
Phone: 5016868274
EMail: BScanlan@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01877564     History of Changes
Other Study ID Numbers: 138647
First Submitted: June 11, 2013
First Posted: June 13, 2013
Results First Submitted: August 9, 2017
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017