MedTrace Logo

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

NCT00650442 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2008-04-01

No results posted yet for this study

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

DRUG

Estradiol Transdermal System Placebo - Alternate Adhesive

single application

DRUG

Estradiol Transdermal System Placebo - Current Adhesive

single application

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
66 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-02-28
Completion
2003-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00650442 on ClinicalTrials.gov