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.

What is the Condition Being Studied?

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.

Age Group
Adults

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).

Study Details

Full Title
Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00107762
NCT: NCT04576104
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment