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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
* Drug: Estradiol Transdermal System Placebo - Current Adhesive


Participation Criteria
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Eligibility Criteria
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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: Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS). 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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transdermal Adhesion |  | within 30 days |