Trial Outcomes & Findings for 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 (NCT NCT01877564)

NCT ID: NCT01877564

Last Updated: 2017-10-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-10-25

Participant Flow

Participants were recruited from the UAMS Gynecologic Oncology Clinic between August 2013 and July 2016.

Subject eligibility was established before treatment randomization and included eligibility assessments, study assessments, lab tests, and pathology assessments.

Participant milestones

Measure	Group 1 - Metformin oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin	Group 2 - No Treatment no metformin for 14-21 days
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1 - Metformin n=6 Participants oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin	Group 2 - No Treatment n=4 Participants no metformin for 14-21 days	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	60.6 years n=93 Participants	61 years n=4 Participants	60.8 years n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 year

Population: data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Group 1 - Metformin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2 - No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 - Metformin n=6 participants at risk oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin	Group 2 - No Treatment n=4 participants at risk no metformin for 14-21 days
Renal and urinary disorders dysuria	16.7% 1/6 • Number of events 1 • 3 months	0.00% 0/4 • 3 months

Additional Information

Beth Scanlan

University of Arkansas for Medical Sciences

Phone: 5016868274

Email: BScanlan@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place