Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
The purpose of this study is to compare the effectiveness of the drug megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia.
Age & Gender
- 18 years ~ 99 years
- Female
Visit Availability
- Standard business hours (M-F, 8-5)
- Visits can be combined with regular clinical appointments
Location
What will be asked of you
This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study involves physical exams; blood tests, study biopsy; specimen collection; questionnaires:( tobacco and alcohol use;COVID-19 exposure and vaccination status); use of study diary. This study is composed of 2 groups; a computer will assign you to one of the 2 groups. group 1: if you are in this group, you will receive megestrol acetate pills by mouth twice a day for 3 to 5 weeks ; group 2: if you are in this group, you will receive megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks. Your doctor will continue to follow your condition for up to 42 days
Incentives
$50 after completion of each study visit, to reimburse you for your time, transportation, parking, and other expenses related to the study
3
up to 3 months
Looking for Specific Volunteers
Able to participate:
- you have a diagnosis of Endometrial Intraepithelial Neoplasia
- you are a candidate for surgical management of your Endometrial Intraepithelial Neoplasia (EIN) with planned hysterectomy
- you have good organ function
- you are diabetic, your blood glucose must be appropriately controlled in the last three months prior to enrollment
- If you are a woman of child-bearing potential you agree to use adequate contraception prior to study entry and for the duration of study participation
Not eligible if:
- you are on Current hormonal therapy or hormone replacement therapy, and you use progestins
- you are currently taking metformin
- You are pregnant or beastfeeding
Contact the Team
Visit Location
Contact & Visit Location
Primary Contact
- Lineberger Clinical Research
- cancerclinicaltrials@med.unc.edu
- (919) 966-4432
Primary Visit Location
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Additional Study Information
Principal Investigator
Leslie Clark
LCCC - Clinical Trials
Study Type
Clinical or Medical
Interventional
Study Topics
Cancer (Uterine (endometrial))
IRB Number
21-1109
