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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Safety Study

Study Primary Completion Date: February 2003

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Estradiol Transdermal System Placebo - Alternate Adhesive
• Placebo Comparator: 2
  • Estradiol Transdermal System Placebo - Current Adhesive

Primary Measures

• Transdermal Adhesion
  • Time Frame: within 30 days
    Safety Issue?: Yes

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).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 66 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Thomas S Clark, M.D. Principal Investigator Kendle International Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650442

Study ID Number: ESTR-02133

ClinicalTrials.gov Identifier: NCT00650442

Health Authority: United States: Institutional Review Board

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