An investigational medication is the term given to a medicine this is still being studied for whether it works and is safe enough to license as a future treatment. It can only be used under strict conditions, such as a clinical trial, like the ACERS study.
What is the investigational medication in the ACERs study?
The Acers Study will look at a potential new medication called AMY109. This study will see if both AMY109 and AMY109 taken with a progesterone medication (called desogestrel) can help lessen the severity of endometriosis compared with desogestrel alone.
This study will also use 2 placebos. A placebo for AMY109 and a placebo for desogestrel. The AMY109-placebo will look just like AMY109 but does not contain any active medicine. The desogestrel-placebo will look just like desogestrel but does not contain any active medicine.
AMY109 is designed to cancel the effects of a protein in the body thought to contribute to the development of endometriosis1.
You will be asked to visit the study site approximately every month during the treatment period.
Desogestrel is a progestin medication. Progestin is a form of progestogen that is commonly found in birth control pills.
You will take 1 capsule of Desogestrel by mouth every day.
Will I receive study medication?
There will be 3 groups in this study. You will be randomly assigned (by chance) to receive either:
- AMY109 and desogestrel-placebo
- AMY109 and desogestrel
- AMY109-placebo and desogestrel
Neither you nor the study doctor will know which group you are in.
Do I qualify for the ACERS study?
1 Nishimoto-Kakiuchi A, et al. A long-acting anti-IL-8 antibody improves inflammation and fibrosis in endometriosis. Sci Transl Med. 2023 Feb 22;15(684):eabq5858. doi: 10.1126/scitranslmed.abq5858. Epub 2023 Feb 22. PMID: 36812343.
C-GB-00001359 | June 2024