Study Details

Open

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

North Carolina (Statewide)

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

In-person visits:
3

Total length of participation:
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

ClinicalTrials.gov

NCT04576104