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

This study has been completed.

Sponsor:

Information provided by:

Mylan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00650442

First received: March 30, 2008

Last updated: March 31, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2008

Last Updated Date

March 31, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Transdermal Adhesion [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00650442 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
single application
Drug: Estradiol Transdermal System Placebo - Current Adhesive
single application

Study Arm (s)

Experimental: 1
Estradiol Transdermal System Placebo - Alternate Adhesive

Intervention: Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
Placebo Comparator: 2
Estradiol Transdermal System Placebo - Current Adhesive

Intervention: Drug: Estradiol Transdermal System Placebo - Current Adhesive

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age: 40-66 years.
Sex: Females only.
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).
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:

Institutionalized subjects will not be used.
Any prior history of skin diseases (eczema, psoriasis, atopic dermatitis).
Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.
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.
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.
Allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).

Gender

Female

Ages

40 Years to 66 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00650442

Other Study ID Numbers ^ICMJE

ESTR-02133

Has Data Monitoring Committee

Not Provided

Responsible Party

Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.

Study Sponsor ^ICMJE

Mylan Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas S Clark, M.D.

Kendle International Inc.

Information Provided By

Mylan Pharmaceuticals

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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