The ACERS study is looking for women with endometriosis
to investigate a new potential treatment.
This is a Chugai sponsored phase 2, randomised, double-blind study evaluating the efficacy and safety
of an investigational product (AMY109) in women with endometriosis’
Endometriosis is a condition where tissue similar to the lining of the womb is found elsewhere in the body. It affects 1 in 10 women in the UK1 and is a debilitating and chronic condition which can cause painful symptoms including heavy and painful periods, pelvic pain, painful bowl movements and in some extreme cases scarring and damage to pelvic organs.
The ACERS study is for women with endometriosis. The study is looking to see if a non-hormonal investigational medication (called AMY109) taken alone or with progesterone (called desogestrel) can help reduce the severity of endometriosis.
You may be able to take part if:
- You are female and aged between 18 and 49.
- Have a diagnosis of endometriosis (confirmed during laparoscopic surgery).
- Willing to have laparoscopic surgery after study treatment.
Other requirements also apply
Your participation will last approximately 2 years 5 months with about 22 visits to the study centre.
It will consist of the following parts:
Washout (if necessary) (4-12 weeks)
You may need to stop taking certain medications before you continue to Screening.
The Screening Phase (21-45 days)
• You will visit the study centre to see if the study is suitable for you.
• You will be asked to complete questionnaires and diaries.
Randomization
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.
Study Treatment (approximately 1 year)
- You will visit the study centre 14 times for assessments.
- The treatment being tested is a non-hormonal investigational medication which you will receive as an intravenous (IV) infusion, which is a drip into a vein, every 4 weeks. The infusion will take 30 to 90 minutes.
You will also take 1 capsule of another study medication by mouth, at about the same time every day.
Post-treatment laparoscopy
- After you have completed the study treatment (approximately 1 year after starting study treatment) you will have a laparoscopy and be admitted to hospital for the procedure.
Follow-up period (approximately 1 year)
- You will visit the study centre approx. 4 times for assessments
Participation in a clinical study is voluntary. You can ask any questions and may leave the study at any time, for any reason.
We will be running the ACERS clinical trial at the following hospitals:
Norfolk and Norwich University Hospital, Norwich
Chelsea and Westminster Hospital, London
Royal Hallamshire Hospital, Sheffield
Guy and St Thomas’, London
Colchester Hospital, Colchester – (not currently accepting study referrals)
Please note we are actively on-boarding new hospitals, so please check back regularly.
C-GB-00001352 | June 2024
¹ Rogers PA, D’Hooghe TM, Fazleabas A, et al. Priorities for endometriosis research: recommendations from an international consensus workshop. Reprod Sci 2009;16(4):335-46.