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Completed

NCT Number: NCT00650442

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

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.

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Key information

Conditions

Healthy

Age range

40 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Estradiol Transdermal System Placebo - Alternate Adhesive

Drug

single application

Estradiol Transdermal System Placebo - Current Adhesive

Drug

single application

Primary outcomes

  1. Transdermal Adhesion

    Time frame: within 30 days

Sponsors and collaborators

Lead sponsor

Mylan Pharmaceuticals Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Apr 1, 2008
Registry last updated
Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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