What is the Adeno study?

Adenomyosis is a condition of the female uterus (womb) causing growth of endometrial (menstrual) tissue within the wall of the uterus that can be associated with heavy and/or painful menstrual periods. It can often be a later stage of previous endometriosis. Treatment is often the use of hormones such as the contraceptive pill or progesterone IUD (which have side-effects in some instances), or for those whose family is complete, removal of the uterus (hysterectomy).

The purpose of this study is to understand the safety of and ability of using the experimental device in the uterus and to understand how it impacts symptoms of Adenomyosis so that it can be evaluated as a potential treatment.

What is the Adeno procedure?

The experimental device is intended to ablate (destroy with energy) uterine tissue to treat patients diagnosed with Adenomyosis.

The Study Procedure with the experimental device will begin with your doctor placing the Study Device (Applicator) into your uterus to reach the specific area. They will then apply energy to that area and repeat this process. The full procedure you will have is expected to take approximately 2 hours in total.

Can you participate in the study?

Yes – if you tick all these boxes: To qualify, we seek women;

• Age between 22-45
• Symptomatic heavy menstrual bleeding or period pain
• Wish to preserve your uterus
• Are not seeking pregnancy

Why should I participate in the ADENO study?

• Priority access to an expert medical team that will care for you throughout the whole study period.
• You may learn more about your condition and feel like you are taking a more active role in improving your health.

What will happen while I am involved in Adeno study?

You will need a medical consultation with the study team. Your doctor will take your history and determine if you are suitable for the study. You will have to undergo some tests, such as an MRI and blood test to confirm you can participate. Once this screening process is done, we can confirm if you are suitable. Once confirmed, we can schedule you for the study procedure.

Not everyone will be of course, however, you still have your gynaecological problems, and these can be discussed and managed, outside of the study.

Is there a cost to participate in the ADENO study?

For those who are recruited to the study, all further study specific costs including consultations, investigations and surgery/hospital costs outside of the normal Medicare rebate, will be covered by the study If you want more information or think you might qualify for the Adeno Study, please.

• 1. Obtain a referral from your GP to the SWEC team referencing the “Adenomyosis Study”
• 2. Preferably, have a specialist gynaecological pelvic ultrasound
• 3. Call (02)9553 6500 to make an initial appointment