RecruitingPhase 1ACTRN12624001286538

The womens Wellness Intrauterine Neuroimmune modulation Study Expansion Group: The effect of a new intrauterine device on pelvic pain in women.

A Phase 1B, single-centre, Expansion Group, randomised, double-blind, parallel-group study to investigate the tolerability and pharmacokinetics of the new Alyra Device (IUD) compared with the commonly used Mirena 'Trademark' Device.


Sponsor

Alyra Biotech Pty Ltd

Enrollment

90 participants

Start Date

Dec 20, 2024

Study Type

Interventional

Conditions

Summary

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUD) for people with period or pelvic pain. The use of IUDs globally is increasing, however some people experience increased pelvic pain in the 3-6 months following insertion, causing them to have the device removed. They then miss out on the benefits that IUDs can provide, such as; reducing your lifetime exposure to synthetic hormones; decreasing the amount of blood loss at each period; as well as decreasing intense period pain, over time with continual use. Alyra Biotech Pty Ltd has developed and patented a novel IUD designed to reduce the severity of post-insertion pain in those that experience it, giving them access to the benefits of IUD use. The objectives of this study are: 1. To determine how the device performs at releasing the appropriate medicinal drugs (pharmacokinetics). 2. To compare the tolerability of the new Alyra device with the currently approved for use in Australia, the Mirena 'Trademark" device. 3. To establish the expected number of days of bleeding following insertion 4. To determine the number of days and intensity of pain experienced following insertion


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Intrauterine devices (IUDs) are one of the most effective and convenient forms of contraception available, but some women experience increased pelvic pain in the weeks after insertion, leading them to have the device removed before they can benefit from it. An Australian company called Alyra Biotech has developed a new IUD designed to reduce post-insertion pain by incorporating medication within the device itself. This early-phase study is evaluating how this new device releases its medication within the body, how it compares to the Mirena IUD in terms of tolerability, and how many days of bleeding and pain women experience after insertion. Participants use a study app to record their symptoms daily for about 90 days. You may be eligible if you are a woman aged 18 to 45 in good general health, have regular menstrual cycles, and agree to use an IUD for approximately 90 days without planning to become pregnant during this time. People with known sensitivity to certain medications, significant gynaecological conditions, or uncontrolled epilepsy are not eligible. There is a urine drug screen as part of screening.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The Alyra intrauterine device – contains ~37mg of levonorgestrel releasing approximately 9.6 micrograms per 24 hours and ~27 mg of amitriptyline releasing approximately 0.35 mg per 24 hours. The devic

The Alyra intrauterine device – contains ~37mg of levonorgestrel releasing approximately 9.6 micrograms per 24 hours and ~27 mg of amitriptyline releasing approximately 0.35 mg per 24 hours. The device will be inserted by a specialist Gynaecologist highly experienced in the placement of IUDs in the general population. The Alyra intrauterine device is placed in exactly the same way, and by the same procedures and practices, as that with a standard Mirena 'Trademark' device. Only study approved Gynaecologists are able to place the Alyra device. The total duration of IUD placement is 90 days (~ 3 months). Throughout the duration of the study, you will attend onsite visits for frequent safety and monitoring checks. These checks will ensure that the device is positioned correctly and are designed to answer any queries that you may have as the study arises. You will also be given a participant information card containing the contact details of your study Gynaecologists, should you need to contact them at any time in regard to your study IUD. Following insertion of the device, participants will complete a daily study specific APP to monitor their experiences of the device.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12624001286538


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