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Phase 4 Study Compares Topical Cream vs Injection for IUD Pain

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Summary

A Phase 4 clinical trial (NCT07546370) registered on ClinicalTrials.gov compares topical prilocaine-lidocaine cream versus lidocaine injection for pain management during intrauterine device insertion. The study will enroll approximately 120 participants who will receive acetaminophen and naproxen as pre-medication, followed by either the topical cream or injectable lidocaine during the procedure. Participants will complete surveys on past medical history, anxiety, and pain outcomes. The trial aims to evaluate safety and efficacy of both analgesic approaches.

“Does prilocaine lidocaine, acetaminophen and naproxen or lidocaine injection, acetaminophen and naproxen reduce pain during intrauterine device insertions.”

NIH , verbatim from source
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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 676 changes logged to date.

What changed

A new Phase 4 clinical trial has been registered on ClinicalTrials.gov to compare two pain management approaches during intrauterine device insertion: topical prilocaine-lidocaine cream versus injectable lidocaine. Both study groups receive acetaminophen and naproxen as pre-medication. The trial will assess pain outcomes, anxiety, and safety of both interventions.

Healthcare providers conducting IUD procedures and patients considering IUD placement may benefit from monitoring the outcomes of this trial, which could inform future pain management protocols for gynecological procedures. Pharmaceutical companies producing lidocaine, prilocaine, or the specified NSAIDs may also find relevance in the comparative safety and efficacy data once published.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Phase 4 NCT07546370 Kind: PHASE4 Apr 22, 2026

Abstract

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.

Conditions: Pain During Intrauterine Device Insertion

Interventions: Prilocaine, Lidocaine, Lidocaine HCl 1%

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial conduct Pain management research Drug safety evaluation
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Clinical Operations Public Health

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