The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared … (NCT07546370) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion
Canada66 participantsStarted 2026-04-14
Plain-language summary
The goal of this clinical trial is to learn if two pain medications used to treat pain during intrauterine device insertions work in persons with a uterus. It will also learn about the safety of the two study medications.
The main questions it aims to answer are:
Does prilocaine lidocaine, acetaminophen and naproxen or lidocaine injection, acetaminophen and naproxen reduce pain during intrauterine device insertions.
Researchers will compare prilocaine lidocaine cream and lidocaine injection to see if it treats pain during an intrauterine device insertion.
Participants will be asked to:
* take acetaminophen and naproxen prior to the procedure.
* receive either prilocaine-lidocaine or lidocaine injection during the procedure
* to fill out a survey on past medical history, anxiety, and pain.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Nulliparous, parous female or non operative trans male
* Participants want to have an IUD for contraception
* Able to provide consent
* Participants are between the ages of 18-45 years old
* Individuals must meet the medical eligibility criteria for an IUD
Exclusion Criteria:
* pregnant or if pregnancy can not be ruled out the day of insertion
* have abnormal uterine bleeding that has not been investigated
* Lupus
* liver disease
* progesterone sensitive tumors
* molar pregnancy
* gynecological malignancy
* breast cancer
* clotting disorders
* uterine anomalies
* septic abortion within last three months
* allergy to progesterone or copper
* pelvic inflammatory disease
* acute malignancies affecting blood
* bacterial endocarditis
* methemoglobinemia
* allergy to prilocaine-lidocaine cream
* actively breastfeeding
* Participants taking beta-blockers and/ or antiarrhythmic drugs
* Individuals who have taken opioids or benzodiazepines within 24 hours prior to the procedure
* Participants who are currently using an IUD
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.