Megestrol acetate compared with megestrol acetate and metformin to prevent endometrial cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to compare 2 different treatment options for endometrial intraepithelial neoplasia (EIN) in the uterus. We want to find out if the combination of metformin and megestrol acetate can decrease the growth of EIN better than megestrol on its own. We will compare how well both options work for women who are planning to either have a hysterectomy or have an intrauterine device (IUD) placed.
Uterine Precancer (Endometrial Intraepithelial Neoplasia [EIN]).
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with EIN based on endometiral tissue sampling
- Plan to have a hysterectomy done or placement of an intrauterine device (IUD)
For more information about this study, please contact the study team at sarah.linhart@duke.edu.
What is Involved?
If you decide to take part in this study, you will get a random assignment (like a coin flip) to either:
- Take megestrol alone; OR
- Take a combination of megestrol + metformin
All of the study medications are drugs that you take by mouth. You will take your assigned study regimen every day for 3-to-5 weeks before your planned procedure (hysterectomy or IUD placement).