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

March 31, 2008 updated by: Mylan Pharmaceuticals Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Kendle International Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age: 40-66 years.
  2. Sex: Females only.
  3. Weight: At least 52 kg (115 lbs) and within 20% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
  4. All subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ECG) performed within 14 days of the initial patch application.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Any prior history of skin diseases (eczema, psoriasis, atopic dermatitis).
  3. Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.

  4. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  5. Subjects who have received an investigational drug within 30 days prior to the initial patch application and/or participated in any transdermal system test for irritation or sensitization within the last 4 weeks.
  6. Allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Estradiol Transdermal System Placebo - Alternate Adhesive
Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
single application
Placebo Comparator: 2
Estradiol Transdermal System Placebo - Current Adhesive
Drug: Estradiol Transdermal System Placebo - Current Adhesive
single application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transdermal Adhesion
Time Frame: within 30 days
within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Pharmaceuticals Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

March 30, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESTR-02133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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