2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy | NCT07768059 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 17, 2026

2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy

A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%/Prilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768059
Lead Sponsor: Mount Sinai Hospital, CanadaOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 174Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Jul 30, 2026Estimated
Primary Completion Date: Jun 30, 2027Estimated
Completion Date: Dec 31, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of Self-application of Lidocaine 2.5%/Prilocaine 2.5% Cream for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
Brief Summary: The aim of this study is to determine if 5g of self-administered topical 2.5% lidocaine/2.5% prilocaine cream, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). Participants will be asked to self-administer the pre-filled vaginal applicator at least 10-15 minutes prior to the procedure. The patient will be asked to rate their pain throughout various steps of the procedure and complete a post-procedure survey afterwards. The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).

Conditions

The medical conditions and diseases this study investigates.

IUD
Endometrial Biopsy

Interventions

The treatments and procedures being evaluated in this study.

2.5% lidocaine/2.5% prilocaine topical cream
VersaPro Cream Base for Compounding

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

Mara Sobel, MDContact

Mara.Sobel@sinaihealth.ca416-586-8273

Locations

Where the study is run and whether each site is currently recruiting.

Ontario Power Generation Building

Toronto, Ontario M5G1Z5, Canada

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Mount Sinai Hospital, CanadaOTHER

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Other registered studies that closely resemble this one.

Detailed Description

The proposed study is a double-blind, placebo-controlled randomized controlled trial (RCT). Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure and post-procedure survey will occur during the same visit.

Two separate randomization schedules will be generated, one for IUD insertion and one for endometrial biopsy, using computer-generated sequences prepared by an independent study coordinator. Randomization will occur via consecutively numbered, opaque, sealed envelopes containing the allocation code. Each participant will be randomly assigned to one of two arms: 1) Intervention (5g of 2.5% lidocaine/2.5% prilocaine cream in a pre-filled vaginal applicator). 2) Placebo (5g of VersaPro cream in a pre-filled vaginal applicator). The research coordinator (who is not involved in direct patient care) will open the allocation envelopes without the presence of the participant or the provider. They will prepare the self-applicators with either 5g of 2.5% lidocaine/2.5% prilocaine cream or 5g of placebo cream to maintain blinding. The patient will be instructed how to self-administer the applicator and dispense all 5g of cream into their vagina in the washroom. A patient education sheet highlighting instructions will also be provided. The patient will wait 10-15 mins and then will be brought into a room for the procedure. Once the procedure begins, pain scores at key intervals will be patient-reported by a 10-point numeric rating scale (NRS) and recorded by a research assistant. A global pain score using a 100mm visual analogue scale (VAS) at 5-minutes following the procedure will also be collected. Post-procedure, there will be a provider-completed questionnaire and a patient satisfaction questionnaire. The provider questionnaire will help describe details of the procedure and complications. The patient satisfaction questionnaire will describe feasibility, acceptability and satisfaction with self-administered cream. The primary outcome will be global pain score at 5-minutes post-procedure, which will be patient-reported by the 100 mm VAS. Secondary outcomes include: pain at specific pain points using a 10-point NRA (baseline after insertion of cream, after insertion of speculum, tenaculum placement, sounding of uterus (IUD only), IUD insertion or endometrial biopsy, and 1-minute post-procedure). Other secondary outcomes include pre- and post-procedure anxiety, procedural characteristics (uterine size, position, IUD type, number of biopsy passes), immediate complication and side effects, procedural difficulty, length of time to complete the procedure, and patient reported feasibility, acceptability, perceived control over pain and satisfaction.