WHO ICTRP trial
The Womens wellness through Intrauterine Neuroimmune modulation study: The…
ACTRN12623000675628 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Recruiting
Key facts
| Trial ID | ACTRN12623000675628 |
|---|---|
| Public title | The Womens wellness through Intrauterine Neuroimmune modulation study: The effect of a new intrauterine device on pelvic pain in women. |
| Scientific title | 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. |
| Primary sponsor | Alyra Biotech Pty Ltd |
| Registry | Australian New Zealand Clinical Trials Registry (ANZCTR) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | Australia |
| Conditions | Pelvic Pain;Dysmenorrhoea;Reproductive Health and Childbirth; Pelvic Pain Dysmenorrhoea Reproductive Health and Childbirth;Reproductive Health and Childbirth - Menstruation and menopause;Reproductive Health and Childbirth - Contraception |
| 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… |
| Registration date | Jun 22, 2023 |
| Target size | 12 |
| Secondary IDs | Sponsor Protocol Number: AB-WIN-001 Sponsor: Alyra Biotech Pty Ltd |
| Registry page | anzctr.org.au |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: