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

NCT07768059 | Not Yet Recruiting

• 1 other identifier: REB # 1630
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

IUD; Endometrial Biopsy

Keywords

pain management; iud insertion; endometrial biopsy; gynecology

Outcome Measures

Primary Outcomes (1)

• Global pain score

  Patient-reported pain measured using the 100-mm Visual Analogue Scale (VAS) 5 minutes following the procedure (endometrial biopsy or IUD insertion). The VAS ranges from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain (a worse outcome).

  Completed by patient 5-minutes post procedure.

Secondary Outcomes (6)

• Pain scores at specific pain points during procedure

  During the procedure

• Anxiety levels

  After application of the cream and waiting for 10 minutes but before starting the procedure as well as at 1-minute after the procedure.

• Immediate complications of endometrial biopsy and/or IUD insertion

  Completed by the provider immediately after the procedure (within 30 mins post procedure).

• Difficulty of procedure

  Completed by the provider immediately after the procedure (within 30 mins post procedure).

• Length of time for procedure completion

  During the procedure

Study Arms (2)

Medicated cream

EXPERIMENTAL

5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator

Drug: 2.5% lidocaine/2.5% prilocaine topical cream

Placebo cream

PLACEBO COMPARATOR

5g of placebo VersaPro topical cream administered with vaginal self-applicator

Other: VersaPro Cream Base for Compounding

Interventions

2.5% lidocaine/2.5% prilocaine topical cream DRUG

5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator

Medicated cream

VersaPro Cream Base for Compounding OTHER

5g of VersaPro cream administered by participant by vaginal self-applicator

Placebo cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
• English speaking participants only

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Ontario Power Generation Building

Toronto, Ontario, M5G1Z5, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mara Sobel, MD

CONTACT

416-586-8273; Mara.Sobel@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 17, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)