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
Starting soon · Phase 4
Conditions studied: Pain During Intrauterine Device Insertion
In brief
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.
Key facts
- Study ID
- NCT07546370
- Run by
- Monakshi Sawhney
- People needed
- 66
- Starts
- 2026-04-14
- Expected to finish
- 2027-04-14
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Woodlawn Medical Clinic — Dartmouth, Nova Scotia, Canada
Full record on ClinicalTrials.gov
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