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A Self-Applied numbing cream might take the sting out of IUD insertion

NCT ID NCT07768059

Symptom relief Sponsor: Mount Sinai Hospital, Canada Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether a numbing cream containing lidocaine and prilocaine, applied at home before the procedure, can reduce pain during IUD insertion or endometrial biopsy. Participants are randomly assigned to receive either the active cream or a placebo, and they rate their pain at several points during the procedure. The goal is to see if this simple approach offers meaningful pain relief.

What this could mean

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

Active substance
A topical cream containing lidocaine and prilocaine, self-applied vaginally before the procedure
What this could lead to
If effective, this could offer a simple, at-home way to reduce pain during IUD insertion or endometrial biopsy, improving comfort for many people.
What could go wrong
The trial is relatively small and early, and the cream may not reduce pain enough to be noticeable. There is also a small risk of allergic reactions or side effects from the numbing medication.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 174 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy * English speaking participants only Exclusion Criteria: * Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours * Misoprostol administration within 24 hours * Confirmed pregnancy * Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus) * Allergy to lidocaine, prilocaine or any other "-caine" type anesthetics or any of the non-medicinal ingredients found in the product * Patients with congenital or idiopathic methemoglobinemia * Patients with glucose-6-phosphate dehydrogenase deficiency * Severe kidney or liver disease * Previous history of local anesthetic systemic toxicity (LAST) * Baseline vital signs of systolic blood pressure \<100, diastolic blood pressure \<60 and/or pulse \<60. * Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible) * Active atopic dermatitis or skin involving vulva, vagina and/or cervix.

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Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

Endometrial biopsy IUD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ontario Power Generation Building

    Toronto, Ontario, M5G1Z5, Canada

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