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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00650442
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
January 2003
February 2003   (final data collection date for primary outcome measure)
Transdermal Adhesion [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00650442 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Healthy
  • Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
    single application
  • Drug: Estradiol Transdermal System Placebo - Current Adhesive
    single application
  • Experimental: 1
    Estradiol Transdermal System Placebo - Alternate Adhesive
    Intervention: Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
  • Placebo Comparator: 2
    Estradiol Transdermal System Placebo - Current Adhesive
    Intervention: Drug: Estradiol Transdermal System Placebo - Current Adhesive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
February 2003
February 2003   (final data collection date for primary outcome measure)

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).
Female
40 Years to 66 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650442
ESTR-02133
Not Provided
Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Thomas S Clark, M.D. Kendle International Inc.
Mylan Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP