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

NCT ID: NCT00650442

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-02-28

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Estradiol Transdermal System Placebo - Alternate Adhesive

Group Type EXPERIMENTAL

Estradiol Transdermal System Placebo - Alternate Adhesive

Intervention Type DRUG

single application

2

Estradiol Transdermal System Placebo - Current Adhesive

Group Type PLACEBO_COMPARATOR

Estradiol Transdermal System Placebo - Current Adhesive

Intervention Type DRUG

single application

Interventions

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Estradiol Transdermal System Placebo - Alternate Adhesive

single application

Intervention Type DRUG

Estradiol Transdermal System Placebo - Current Adhesive

single application

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

66 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Mylan Inc.

Principal Investigators

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Thomas S Clark, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kendle International Inc.

Locations

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Kendle International Inc.

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.mpibiostudies.com

Mylan Pharmaceuticals Inc. - Clinical Trial Results

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

Other Identifiers

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ESTR-02133

Identifier Type: -

Identifier Source: org_study_id