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Do you have EIN?

Endometrial intraepithelial neoplasia (EIN), also known as Complex Atypical Hyperplasia (CAH), is a change in the lining of the uterus (also called the endometrium) that can lead to cancer of the uterus. Uterine/endometrial cancer is the most common gynecologic cancer and its incidence is increasing rapidly.

 

The usual approach for women diagnosed with EIN/CAH is surgical - hysterectomy (removal of the uterus) without any prior medical treatment with pills. But some women may want to avoid hysterectomy because they want to have children, or because there are health risks to major surgery. We are doing this study to see if it is possible to treat EIN by changing the lining of the uterus at the cellular level and prevent it from turning into uterine cancer, without doing a hysterectomy.

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NWU2015-06-03

Megestrol Acetate Compared with Megestrol Acetate and Metformin to Prevent Endometrial Cancer

Principal Investigator: Emma Barber, MD, MS
Northwestern University

Currently, a drug called megestrol acetate, also called megace, can be used for treatment of EIN without surgery. Megestrol acetate is a synthetic version of the human hormone progesterone. It treats breast cancer and endometrial cancer by affecting female hormones involved in cancer growth. However, it has a high failure rate in preventing cancer growth from EIN, and hysterectomy is still needed for most women. The goal of this study is to improve the results of megestrol acetate treatment, by combining it with an anti-diabetes drug called metformin. Although research suggests that metformin may have anti-cancer properties, it has not yet been proven to be safe and effective to treat EIN.  We will compare the effectiveness of megestrol acetate alone with the combination of megestrol acetate and metformin in reducing the growth of EIN. If we find that the combination of megestrol acetate with metformin is better at reducing EIN growth than megestrol acetate alone, we will plan further research with this combination to try and prevent EIN from turning into uterine/endometrial cancer. This study is looking for volunteers who have been diagnosed with EIN and are planning a hysterectomy or progestin intrauterine device (IUD) placement. We will enroll 50 participants at institutions across the country.

 

You may be eligible if:

  • You have been diagnosed with EIN/CAH, endometrial intraepithelial neoplasia or atypical hyperplasia

  • You are over 18 years of age

If you think you may be eligible, you can contact a study coordinator:

NORTHWESTERN UNIVERSITYjadekaur.virdi@northwestern.edu– Chicago, Illinois; annie.eliopoulos@nm.org - Winfield, Illinois

UNIVERSITY OF COLORADOSAMANTHA.HOPP@CUANSCHUTZ.EDU – Aurora, Colorado

DUKE UNIVERSITYtaylor.hayes@duke.edu – Durham, North Carolina

UNIVERSITY OF NORTH CAROLINAmelisa_ramirez-pineda@med.unc.edu - Chapel Hill, North Carolina

 

More Information: https://clinicaltrials.gov/ct2/show/NCT04576104

NWU2016-08-02

Additional Resources

Study Brochure 

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EIN Fact Sheet:

From the National Cancer Institute Division of Cancer Prevention Blog:

"Rising Endometrial Cancer Rates Spur New Approaches to Prevention"

Study Video 

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