The Womens wellness through Intrauterine Neuroimmune modulation study: The effect of a new intrauterine device on pelvic pain in women.
A Phase 1B, single-centre, Initial 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.
Alyra Biotech Pty Ltd
12 participants
Dec 18, 2023
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 determine how much of the medicinal drugs are remaining in the device at study end. 4. To determine the effects of the Alyra Device on the endometrium using endometrial biopsies.
Eligibility
Inclusion Criteria8
- Is in good general health.
- Agrees to have an IUD for ~84 days.
- Agrees to take oral temperature recordings.
- Has a history of regular menstrual cycles (i.e. every 21-35 days).
- Has a uterus with no significant abnormalities.
- Has a minimum of one vaginal birth
- Agrees to record their symptoms daily and use of medications on a study specific APP.
- Does not plan to become pregnant during their study involvement.
Exclusion Criteria7
- Know sensitivity, intolerance, or allergy to non-steroidal anti-inflammatory drugs, paracetamol, ibuprofen, levonorgestrel, amitriptyline, or any components of the intrauterine device.
- Has a positive urine drug screen.
- Has a significant gynaecological condition.
- Has undergone a hysterectomy or oophorectomy.
- Has recurrent or current pelvic infections.
- Has severe arterial disease.
- Has uncontrolled epilepsy.
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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 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 84 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)
View Full Details on ANZCTR
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ACTRN12623000675628