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New treatment option for IUD
Official title 3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion
ClinicalTrials.gov ID: NCT07295054
What this study is testing
What is Methoxyflurane?
Methoxyflurane is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for iud.
Also referred to as Penthrox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- Patients with a uterus.
- Ages 18 to 55 years.
- Undergoing any intrauterine device (IUD) insertion.
- English-speaking participants.
- Ability to use an inhaler device.
You likely can't join if
- Inability to provide informed consent.
- Confirmed pregnancy.
- Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the...
- Use of cannabis within 24 hours prior to the intervention.
- Administration of misoprostol within 24 hours prior to the intervention.
- Altered level of consciousness due to any cause, including head injury, drugs, or alcohol.
See the full eligibility criteria
- Patients with a uterus.
- Ages 18 to 55 years.
- Undergoing any intrauterine device (IUD) insertion.
- English-speaking participants.
- Ability to use an inhaler device.
- Willing to receive a cervical block for their IUD insertion
- Inability to provide informed consent.
- Confirmed pregnancy.
- Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention.
- Use of cannabis within 24 hours prior to the intervention.
- Administration of misoprostol within 24 hours prior to the intervention.
- Altered level of consciousness due to any cause, including head injury, drugs, or alcohol.
- History of severe adverse reactions to Penthrox (methoxyflurane) or other halogenated anesthetic agents, or to any ingredient in the formulation (including non-medicinal ingredients or container components).
- Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis.
- Clinically significant renal and/or liver impairment.
- Known or genetic susceptibility to malignant hyperthermia.
- Clinically evident hemodynamic or cardiovascular instability, or respiratory depression.
- Not NPO according to hospital guidelines.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.