NCT00649896

Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day

Comparative Evaluation of the Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System (0.025 mg/Day; Mylan) and Climara® Transdermal System (0.025 mg/Day; Berlex) in Healthy Postmenopausal Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mylan Estradiol Transdermal System 0.025 mg/day
DRUG	Climara® Transdermal System 0.025 mg/day

Timeline

• Start date: 2003-08-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2008-04-01
• Last updated: 2008-04-01

Locations

1 site across 1 country: United States