that you need
If you have been told that you need uterine surgery, you
should know about intrauterine adhesions (IUAs) and an
exciting new clinical trial that is evaluating a new product
that may prevent them.
To find out more about IUAs as well as the clinical trial,
find more information below.
If your doctor has recommended uterine surgery, you should know about intrauterine adhesions (IUAs)
Commonly referred to as “Asherman's Syndrome”, IUAs are bands of fibrous tissue that form in the uterus, often in response to a uterine procedure. As many as 40% of women who have had some type of surgical procedure inside the uterus develop Asherman's Syndrome. Your doctor can see these adhesions using ultrasound or by putting a thin telescope inside the uterus; a procedure called hysteroscopy.
The thicker the bands of scar tissue, the more they can cause the uterine cavity to narrow, resulting in pain, skipped, sparse or absent menstrual periods as well as recurring pregnancy loss and other pregnancy complications.
What are IUAs?
You may be able to participate in a clinical trial for a product designed to prevent IUAs
Working closely with leading physicians, Rejoni™ is conducting a clinical trial to learn if a soft gel-like material, called Juveena™ Hydrogel may prevent intrauterine adhesions after uterine surgery.
How does the clinical study work?
In this study, potential participants are those who are undergoing uterine surgery either to remove fibroids
or to disrupt existing adhesions in a procedure called adhesiolysis.
Qualified participants will be randomly assigned to either receive instillation of the hydrogel (treatment group) directly after completion of the uterine surgery or to not have the hydrogel instilled (control group). Two women will be assigned to the treatment group for every one assigned to the control group.
does it cost to participate?
You will not incur any extra costs for participating in this trial. You will receive compensation for any reasonable travel, and parking expenses associated with the research study visits.
What is Juveena™ Hydrogel and how does it work?
The intrauterine surgery will be performed per your doctor’s routine standard regardless of your assigned trial group. If you are assigned to the treatment group, the Juveena™ Hydrogel, made of PEG or polyethylene-glycol, will be instilled using a thin flexible catheter into the uterus directly after your intrauterine surgery (see images below). The Juveena™ Hydrogel fills the uterus, keeping the walls of the uterus apart during the healing process which may prevent adhesions from forming.
The hydrogel will then become a liquid after a couple of weeks, and it is naturally discharged from the body.
Have PEG hydrogels been used in the body before?
Yes. Hydrogels made of PEG have a long history of safe and effective use in the body and are the main ingredient of FDA approved products that have helped millions of patients. PEG is also widely used in drug manufacturing; however, some people have allergies to PEG and the blue dye that is used in the device (FD&C #1 Blue Dye). Let your doctor know if you have allergies to these materials.