Trials / Completed
CompletedNCT00925353
The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Mountain States Tumor and Medical Research Institute · Academic / Other
- Sex
- Female
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 4% lidocaine gel | 1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2009-06-22
- Last updated
- 2013-12-23
- Results posted
- 2013-12-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00925353. Inclusion in this directory is not an endorsement.