NCT00650442

Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System

Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 40 Years – 66 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to compare the adhesive quality of the current Mylan estradiol placebo transdermal system, with that of an alternate second generation Mylan estradiol placebo transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Estradiol Transdermal System Placebo - Alternate Adhesive	single application
DRUG	Estradiol Transdermal System Placebo - Current Adhesive	single application

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2008-04-01
• Last updated: 2008-04-01

Locations

1 site across 1 country: United States