An Endometrial Cancer Chemoprevention Study of Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

May 30, 2013

Primary Completion Date

May 30, 2024

Study Completion Date

May 30, 2024

Conditions
Gynecology
Interventions
DRUG

Metformin

"Participants gradually increase the dose of metformin by mouth as listed below:~Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day~After week 4, participant continues to take 2 capsules of metformin 2 times each day.~Each capsule is 425 mg."

OTHER

Placebo

Placebo taken by mouth twice daily for 4, 30 day cycles.

PROCEDURE

Endometrial Biopsy

Endometrial biopsies obtained at baseline and after 4 months.

BEHAVIORAL

Lifestyle Intervention

Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.

BEHAVIORAL

Questionnaires

Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT01697566 - An Endometrial Cancer Chemoprevention Study of Metformin | Biotech Hunter | Biotech Hunter