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New inhaler could ease IUD insertion pain

NCT ID NCT07295054

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether inhaling a drug called methoxyflurane (Penthrox) can reduce pain and anxiety during IUD insertion. About 110 people will receive either the drug or a placebo inhaler. The goal is to see if this quick, self-administered pain relief improves patient satisfaction compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methoxyflurane (Penthrox) inhaled via a handheld inhaler
What this could lead to
If it works, this could offer a fast, self-administered pain relief option for IUD insertion, making the procedure more comfortable.
What could go wrong
This is a small, early-phase trial (110 participants) comparing methoxyflurane to a placebo inhaler. It may not show a meaningful benefit, and side effects like dizziness or nausea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with a uterus. 2. Ages 18 to 55 years. 3. Undergoing any intrauterine device (IUD) insertion. 4. English-speaking participants. 5. Ability to use an inhaler device. 6. Willing to receive a cervical block for their IUD insertion Exclusion Criteria: 1. Inability to provide informed consent. 2. Confirmed pregnancy. 3. Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention. 4. Use of cannabis within 24 hours prior to the intervention. 5. Administration of misoprostol within 24 hours prior to the intervention. 6. Altered level of consciousness due to any cause, including head injury, drugs, or alcohol. 7. 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). 8. Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis. 9. Clinically significant renal and/or liver impairment. 10. Known or genetic susceptibility to malignant hyperthermia. 11. Clinically evident hemodynamic or cardiovascular instability, or respiratory depression. 12. Not NPO according to hospital guidelines.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Women's College Hospital

    RECRUITING

    Toronto, Ontario, M5S 1B2, Canada

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