Megestrol acetate compared with megestrol acetate and metformin to prevent endometrial cancer

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)

Looking for Healthy Participants

Yes

What is Involved?

Description

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).

Locations

Duke University Hospital

Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

Yes

Study Details

Full Title

Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

Principal Investigator

Angeles

Secord

Protocol Number

PRO00107762

NCT ID

NCT04576104

Phase

Enrollment Status

Open to Enrollment

ClinicalTrials.gov