PainPhase 4NCT05970354
EMLA Cream as Analgesic for Outpatient Gynecological Procedures
A Phase 4 study testing EMLA Cream and VersaPro Cream Base for Compounding in people with Pain, run by CAMC Health System at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. 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
- Pain
- What is being tested?
- EMLA Cream and VersaPro Cream Base for Compounding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies
Who cannot join
- Known hypersensitivity to amide anesthetics
- Pre-existing methemoglobinemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center Institute for Academic Medicine
Charleston, West Virginia, 25302
About this study
Official title: Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial
The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:
- Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?
Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.
Read the detailed description
Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.
- Conditions
- Pain
- Being tested
- EMLA Cream, VersaPro Cream Base for Compounding
- Keywords
- intra-uterine device insertion, hysteroscopy, endometrial biopsy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA CreamDrug
Eutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%)
VersaPro Cream Base for CompoundingDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| EMLA Cream | Active comparator | 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure Receives: Drug: EMLA Cream |
| VersaPro Cream | Placebo comparator | 5 grams will be applied to patient's cervix 7 minutes before gynecological procedure Receives: Drug: VersaPro Cream Base for Compounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Pain Score 1
Scale of 0-10 on a self-reported pain score
Measured: At time of speculum placement for procedure
Visual Analogue Scale Pain Score 2
Scale of 0-10 on a self-reported pain score
Measured: At start of cervical manipulation
Visual Analogue Scale Pain Score 3
Scale of 0-10 on a self-reported pain score
Measured: 2 minutes after speculum removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Sep 2023
- Primary completion30 Nov 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Poulsen, DO, Principal investigator, West Virginia School of Medicine--Charleston Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970354
- Sponsor's protocol ID
- 22-910
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial
- ClinicalTrials.gov ID
- NCT05970354
- Acronym / sponsor ID
- 22-910
- Conditions
- Pain
- Keywords
- intra-uterine device insertion, hysteroscopy, endometrial biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 1 Aug 2023 (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 goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:
- Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?
Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.
Detailed description
Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA Cream | Active comparator | Drug: EMLA Cream5 grams will be applied to patient's cervix 7 minutes before gynecological procedure |
| VersaPro Cream | Placebo comparator | Drug: VersaPro Cream Base for Compounding5 grams will be applied to patient's cervix 7 minutes before gynecological procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies
Key exclusion criteria (2 listed)
- Known hypersensitivity to amide anesthetics
- Pre-existing methemoglobinemia
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 |
|---|---|---|
| EMLA CreamEutectic Mixture of Local Anesthetics (Lidocaine 2.5% and Prilocaine 2.5%) | Drug | EMLA Cream |
| VersaPro Cream Base for CompoundingPlacebo | Drug | VersaPro Cream |
Primary outcome
Visual Analogue Scale Pain Score 1
Time frame: At time of speculum placement for procedure
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 2
Time frame: At start of cervical manipulation
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 3
Time frame: 2 minutes after speculum removal
Scale of 0-10 on a self-reported pain score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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. This study is not recruiting at the moment.
Alex Poulsen, DO principal investigator
West Virginia School of Medicine--Charleston Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMLA Cream and VersaPro Cream Base for Compounding in people with Pain, run by CAMC Health System at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 31 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Pain Score 1 (time frame: At time of speculum placement for procedure). The study lists 3 primary outcomes in all. 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 31 Aug 2026.