Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
Information source: Mylan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Estradiol Transdermal System Placebo - Alternate Adhesive (Drug); Estradiol Transdermal System Placebo - Current Adhesive (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s):
Thomas S Clark, M.D., Principal Investigator, Affiliation: Kendle International Inc.
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.
Clinical Details
Official title: Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers
Study design: Other, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Safety Study
Primary outcome: Transdermal Adhesion
Eligibility
Minimum age: 40 Years.
Maximum age: 66 Years.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: January 2003
Ending date: February 2003
Last updated: March 31, 2008
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