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Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Condition: Endometrial Hyperplasia · Sponsor: Bayer
About this study
Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer. Currently, there are no approved treatments for NAEH and that is why there is still an unmet medical need. The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone. In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body. The main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, part…
This description comes directly from the study's public registry record.
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Locations (38)
| Velocity Clinical Research - Phoenix | Phoenix, Arizona, United States | — |
| Cornerstone Clinic for Women - Aldersgate | Little Rock, Arkansas, United States | — |
| Alliance Clinical West Hills | West Hills, California, United States | — |
| Sweet Hope Research Specialty, Inc. - Hialeah | Hialeah, Florida, United States | — |
| New Age Medical Research Corp. | Miami, Florida, United States | — |
| Entrust Clinical Research | Palmetto Bay, Florida, United States | — |
| Emerald Coast Clinical Research | Panama City, Florida, United States | — |
| Paramount Research Solutions | College Park Location | Atlanta, Georgia, United States | — |
| Office of Dr. Cindy Basinski, LLC | Evansville, Indiana, United States | — |
| Velocity Clinical Research - Lafayette | Lafayette, Louisiana, United States | — |
| Southern Clinical Research Associates | Metairie, Louisiana, United States | — |
| Omni Fertility and Laser Institute | Shreveport, Louisiana, United States | — |
+ 26 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06904274