IUDNCT07768059
2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy
A study testing 2.5% lidocaine/2.5% prilocaine topical cream and VersaPro Cream Base for Compounding in people with IUD and Endometrial Biopsy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD, Endometrial Biopsy
- What is being tested?
- 2.5% lidocaine/2.5% prilocaine topical cream and VersaPro Cream Base for Compounding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
- English speaking participants only
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Ontario Power Generation Building
Toronto, Ontario, M5G1Z5
Mara Sobel, MD, 416-586-8273, mara.sobel@sinaihealth.ca
Mara Sobel, MD
About this study
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
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).
Read the 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.
- Conditions
- IUD, Endometrial Biopsy
- Being tested
- 2.5% lidocaine/2.5% prilocaine topical cream, VersaPro Cream Base for Compounding
- Keywords
- pain management, iud insertion, endometrial biopsy, gynecology
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% lidocaine/2.5% prilocaine topical creamDrug
5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator
VersaPro Cream Base for CompoundingOther
5g of VersaPro cream administered by participant by vaginal self-applicator
| Study group | Role | What they receive |
|---|---|---|
| Medicated cream | Experimental | 5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator Receives: Drug: 2.5% lidocaine/2.5% prilocaine topical cream |
| Placebo cream | Placebo comparator | 5g of placebo VersaPro topical cream administered with vaginal self-applicator Receives: Other: VersaPro Cream Base for Compounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Completed by patient 5-minutes post procedure.
Secondary outcomes (6)
Pain scores at specific pain points during procedure
Pain scores at specific pain points: baseline after insertion of cream, after insertion of the speculum, removal of excess cream with gauze, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure, which will be patient-reported verbally during the procedure on a scale from 0 (i.e. no pain) to 10 (worst pain imaginable). When more than one biopsy pass is required, only pain after the first pass will be recorded.
Measured: During the procedure
Anxiety levels
Patient-reported anxiety before and after the procedure, measured using a 5-point Likert scale ranging from 1 (very anxious) to 5 (very calm). Higher scores indicate less anxiety (a better outcome).
Measured: 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
Provider-reported immediate complications associated with the endometrial biopsy and/or IUD insertion, including difficulty of procedure, vasovagal reaction, vital sign changes, or other procedure-related complications. This will be assessed by the presence or absence of specific procedure-related complications.
Measured: Completed by the provider immediately after the procedure (within 30 mins post procedure).
Difficulty of procedure
The difficulty of the procedure will be assessed with a Likert scale from 1 (least difficult) to 5 (most difficulty), provider reported.
Measured: Completed by the provider immediately after the procedure (within 30 mins post procedure).
Length of time for procedure completion
Time will be recorded via stopwatch
Measured: During the procedure
Patient-reported acceptability, feasibility, and satisfaction with vaginal cream self-administration
Patient-reported acceptability and satisfaction with self-administration will be assessed using a study-specific questionnaire evaluating ease and comfort of self-administration, perceived control, satisfaction with pain control and the self-application process, and willingness to use self-administration for a future gynecologic procedure.
Ease of administration, comfort with self-administration, satisfaction with pain control, satisfaction with the self-application process, and likelihood of choosing self-administration again will each be assessed using 5-point Likert scales ranging from 1 to 5, with higher scores indicating greater ease, comfort, satisfaction, or likelihood of future use (a better outcome). Additional acceptability measures, including confidence in correct application, difficulty with application, perceived control, and willingness to choose the same pain-control method in the future, will be reported descriptively based on categorical responses (Yes/No/Unsure)
Measured: Completed by the patient immediately after the procedure (within 30 mins post procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Sobel, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768059
- Sponsor's protocol ID
- REB # 1630
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07768059
- Acronym / sponsor ID
- REB # 1630
- Conditions
- IUD, Endometrial Biopsy
- Keywords
- pain management, iud insertion, endometrial biopsy, gynecology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicated cream | Experimental | Drug: 2.5% lidocaine/2.5% prilocaine topical cream5g of 2.5% lidocaine/2.5% prilocaine topical cream administered with vaginal self-applicator |
| Placebo cream | Placebo comparator | Other: VersaPro Cream Base for Compounding5g of placebo VersaPro topical cream administered with vaginal self-applicator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any participant ≥18 years presenting for an IUD insertion or endometrial biopsy
- English speaking participants only
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.5% lidocaine/2.5% prilocaine topical cream5g of 2.5% lidocaine/2.5% prilocaine topical cream administered by participant by vaginal self-applicator | Drug | Medicated cream |
| VersaPro Cream Base for Compounding5g of VersaPro cream administered by participant by vaginal self-applicator | Other | Placebo cream |
Primary outcome
Global pain score
Time frame: Completed by patient 5-minutes post procedure.
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).
6 secondary outcomes
Pain scores at specific pain points during procedure
Time frame: During the procedure
Anxiety levels
Time frame: 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
Time frame: Completed by the provider immediately after the procedure (within 30 mins post procedure).
Difficulty of procedure
Time frame: Completed by the provider immediately after the procedure (within 30 mins post procedure).
Length of time for procedure completion
Time frame: During the procedure
Patient-reported acceptability, feasibility, and satisfaction with vaginal cream self-administration
Time frame: Completed by the patient immediately after the procedure (within 30 mins post procedure).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.5% lidocaine/2.5% prilocaine topical cream and VersaPro Cream Base for Compounding in people with IUD and Endometrial Biopsy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Sobel, MD (416-586-8273, Mara.Sobel@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global pain score (time frame: Completed by patient 5-minutes post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.