World-first trial of IUD that can also treat period and pelvic pain

A breakthrough contraceptive that also treats period pain, pelvic pain, fatigue and even headaches is seeking volunteers for a trial of the SA-made world-first medical device.

A breakthrough contraceptive device that potentially cures period pain, other pelvic pain and even headaches is seeking volunteers for its second human trial.

The revolutionary device set to change the lives of millions of women worldwide was developed, tested, trialled and manufactured in Adelaide

Adelaide-based Alyra Biotech’s development of a novel intra-uterine device (IUD) to treat pelvic pain in women successfully completed the first-in-human study of 12 participants in October 2024.

Dr Susan Evans with Rene Boesten who participated in the first successful trial of the revolutionary IUD. Picture: Kelly Barnes

More than 400 women applied to be considered.

Now a second trial is seeking 90 participants.

Volunteers must live in Adelaide, be aged between 18 – 45 years, experience pain with periods and be able to attend six onsite visits to the PARC clinical trials unit at the Royal Adelaide Hospital over four months.

They also must be willing to take 10 minutes every day for four months recording their symptoms on the custom Alyra APP and not used an IUD during the last 60 days.

It will include women with or without endometriosis, and with or without children. Details and how to apply are available at alyrabiotech.com.

Alyra Biotech founder, Adelaide gynaecologist Associate Professor Susan Evans was granted a US patent on the revolutionary technology in 2022 which followed five years of development.

“With devices made at TekCyte in Mawson Lakes, tested at UniSA, and the trial at PARC research centre in the Royal Adelaide Hospital this is a truly Adelaide process,” Dr Evans said.

“And a world first.”

She said people talk about a “gut-brain axis” but the Alyra Device works on the “uterus-brain axis” where the uterus talks to the brain via the immune system.

This can see excess immune activation in the uterus sending signals to the central nervous system which can result in symptoms including pain — both inside and outside the pelvis — fatigue, mood disorders, bowel symptoms and poor sleep.

Alyra Biotech has developed products to turn down the excess immune activation in the uterus to reduce these symptoms.

A low dose immune inhibitor is added to the IUD for sustained release, making it a combined contraceptive and pain prevention device.

The inhibitor drug has known efficacy and long-term safety data in humans.

“The drug in the device turns down the immune activation — it targets the problem to reduce the symptoms,” Dr Evans said.

This aims to reduce premenstrual syndrome symptoms, pelvic pain, bowel and bladder symptoms, headache, fatigue and endometriosis-associated pain.

Rene Boesten, 30, participated in the first trial after suffering “horrible period pain for 18 years with no relief,” and wanted to be involved in something that can change this experience for others.

“My overall wellbeing was significantly improved and pain reduced immensely compared to other modes of birth control,” she said.

“I would definitely use it if it became available, it’s such an important step forward in women’s health.”

Originally published as World-first trial of IUD that can also treat period and pelvic pain