The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Completed · Phase 4

Conditions studied: Adverse Effects

In brief

The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).

Key facts

Study ID

NCT00925353

Run by

Mountain States Tumor and Medical Research Institute

People needed

13

Starts

2010-01-01

Expected to finish

2010-02-01

Last updated by the study team

2013-12-23

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 35 years and older
• intact skin on breasts and chest wall

You may not qualify if…

• sensitivity or allergy to lidocaine
• liver or kidney dysfunction
• pregnant
• breast feeding
• currently smoke or chew tobacco
• used lidocaine products within 48 hours of baseline lab, EKG, or gel application
• exhibit neurological or cardiac signs or symptoms prior to gel application
• are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral contraceptives
• history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure
• heart rate below 60 or above 100 beats per minute
• systolic blood pressure below 95 or above 180 mm Hg
• PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450 msec, or evidence of WPW on EKG
• have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker
• have had cancer, surgery, trauma, or myocardial infarction in the past 6 months

Where it is running

• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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