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:<ul>
<li>Are diagnosed with EIN based on endometiral tissue sampling</li>
<li>Plan to have a hysterectomy done or placement of an intrauterine device (IUD)</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: sarah.linhart@duke.edu">sarah.linhart@duke.edu.</a>
<li>Are diagnosed with EIN based on endometiral tissue sampling</li>
<li>Plan to have a hysterectomy done or placement of an intrauterine device (IUD)</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: sarah.linhart@duke.edu">sarah.linhart@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Looking for Healthy Participants
Yes
What is Involved?
If you decide to take part in this study, you will get a random assignment (like a coin flip) to either:<ul>
<li>Take megestrol alone; OR</li>
<li>Take a combination of megestrol + metformin</li></ul>
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).
<li>Take megestrol alone; OR</li>
<li>Take a combination of megestrol + metformin</li></ul>
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
II
Enrollment Status
Open to Enrollment