Period Pain Study
We are recruiting for a clinical trial investigating a potential new intrauterine device (IUD) to help people with difficult to manage period and pelvic pain, including people with endometriosis.
In order to be considered to take part in the study, you’ll need to meet all of the following:
- 18 - 45 years old
- Pre-existing dysmenorrhoea
- History of regular menstrual cycles
- Have had at least one child (to assist with device insertion)
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If you take part in the research study, there will be:
Reimbursement of costs
Participants will be paid $2000 on completion of the study
Free study-related medical care
All procedures will be provided by specialist gynaecologists, Professor Louise Hull, Dr Sally Reid, Dr Tran Nguyen and Dr Rituparna Dutta.
Ongoing medical support
Receive a tailored pain management plan from Dr Susan Evans, gynaecologist and pain physician on completion of the study.
Contribution to medical research
Help advance knowledge and treatment outcomes for people with period and pelvic pain.
Who can take part in this study?
To be eligible for participation, you will need to meet all the following:
- Live in Adelaide.
- Are between 18 - 45 years of age.
- Experience pain with periods and have regular monthly menstrual periods when not on the pill.
- Have had at least one child.
- Are able to attend onsite visits to the PARC clinical trials unit at the Royal Adelaide Hospital.
- Are happy to record your symptoms on a study-related app each day.
- Have not had an IUD in the last 60 days.
Who is unable to take part in this study?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- Have used hormonal tablets, implants, injections or intrauterine devices within 30 days prior to the screening visit.
- Pregnancy in the past 3 months, or breastfeeding.
- Any serious or unstable diseases or medical conditions that might interfere with the conduct of the study (these will be discussed during phone screening).
- A known sensitivity or allergy to any components in the medical device (these will be discussed during phone screening).
- Ongoing severe symptoms of COVID-19.
- Have participated in, or are currently participating in, another clinical trial within three months prior to the screening visit that might interfere with the study objectives (this will be discussed during phone screening).
- Some SSRI medications.
Additional eligibility criteria apply.
Please do not hesitate to contact our dedicated Patient Experience team for a detailed discussion about your suitability for participation.
How long will the study take?
If you are deemed eligible for the study, your participation is expected to last 159 days (approximately 5 months and one week), and you will be required to attend the study site up to 14 times. This includes:
- A screening period of up to 40 days, during which you will undergo physical examinations and medical tests to determine your eligibility to participate.
- Randomisation into one of two treatment groups.
- Device insertion with either the study device or a MirenaTM device, an overnight stay at the PARC centre with blood tests daily for 7 days
- A treatment period of 84 days (or 3 menstrual cycles) after the device has been inserted, during which you will revisit the study site 3 times for safety monitoring.
- Device removal, and a follow-up phone call to discuss any remaining questions or concerns in relation to the study.
- Throughout the study, you will also be required to record your symptoms and medication use on a daily basis using an app-based ePRO (Electronic Patient Reported Outcomes) questionnaire.
Eligible participants will have a 75% (three in four) chance of receiving the study device. One in four participants will receive the MirenaTM device to help establish the safety and efficacy of the study device in comparison to current intrauterine devices. This is a double-blind study, which means neither you nor the study doctor will know which device you receive.
Participation in this research study is voluntary, and you may withdraw at any time.
What is the purpose of this study?
This study aims to investigate how well the study device is tolerated compared to the commonly used MirenaTM device in people who experience pelvic pain during periods.
The study device includes a component that helps reduce excessive immune system activity in the uterus, which is linked to a range of symptoms including chronic pain, digestive issues, fatigue, and more.
What is pelvic and period pain?
Period pain is the pain experienced by women during menstruation, and it occurs when the muscular walls of the uterus contract.
People with more severe period pain often have additional symptoms including pelvic pain at other times, bowel or bladder troubles, fatigue or mood disorders.
Why is this study important?
One in five young women suffer from severe period pain, which can develop into chronic pelvic pain when underlying conditions, including endometriosis, contribute to ongoing inflammation and structural changes in the pelvic region.
Chronic pelvic pain can, in turn, stop a person from sleeping, doing the things they love, and ultimately reduce their overall quality of life.
As such, there is a global unmet human need for an effective, easy-to-use product that prevents the transition from severe period pain to chronic pelvic pain with few adverse effects and minimal interruption to natural hormonal cycles.
Who is sponsoring this study?
This study is being sponsored by Alyra Biotech, an Australian biopharmaceutical company founded in 2017 by world-renowned gynaecologist and pain physician Dr Susan Evans.
Alyra Biotech is exclusively committed to improving the management of pain and wellbeing in women.
Driven by patient experience and backed by scientific innovation, their novel products have potential application in the treatment of pelvic pain, dysmenorrhea, endometriosis-related pain, irritable bowel syndrome, and other conditions affecting the uterus, bladder, or bowel or women.
Where is my nearest study site?
PARC Clinical Research, located at the Royal Adelaide Hospital, Port Road, Adelaide SA 5000.
What if I have other questions about the study?
We're here for you. Click or tap the 'Contact us' button below to send an email to our Patient Experience team: