Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial.
Hiroshi IshikawaOsamu YoshinoFuminori TaniguchiTasuku HaradaMikio MomoedaYutaka OsugaTamiki HikakeYouko HattoriMichiko HanawaYosuke InabaHideki HanaokaKaori KogaPublished in: Reproductive health (2024)
This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).
Keyphrases
- pain management
- phase iii
- clinical trial
- chronic pain
- open label
- randomized controlled trial
- phase ii
- study protocol
- polycystic ovary syndrome
- double blind
- placebo controlled
- neuropathic pain
- type diabetes
- systematic review
- spinal cord
- pregnant women
- metabolic syndrome
- pregnancy outcomes
- cervical cancer screening
- spinal cord injury
- climate change
- breast cancer risk