2.5% Lidocaine/2.5% Prilocaine Cream for IUD Insertion and Endometrial Biopsy

MS
Overseen ByMara Sobel, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mount Sinai Hospital, Canada

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Medicated creamExperimental Treatment1 Intervention
Group II: Placebo creamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials
210
Recruited
70,700+