Status:
COMPLETED
Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
FEMALE
40-66 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00650442
Start Date
January 1 2003
End Date
February 1 2003
Last Update
April 1 2008
Active Locations (1)
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1
Kendle International Inc.
Morgantown, West Virginia, United States, 26505