Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System - Full Text View

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00650442

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Estradiol Transdermal System Placebo - Alternate Adhesive Drug: Estradiol Transdermal System Placebo - Current Adhesive	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:

Transdermal Adhesion [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	39
Study Start Date:	January 2003
Study Completion Date:	February 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Estradiol Transdermal System Placebo - Alternate Adhesive	Drug: Estradiol Transdermal System Placebo - Alternate Adhesive single application
Placebo Comparator: 2 Estradiol Transdermal System Placebo - Current Adhesive	Drug: Estradiol Transdermal System Placebo - Current Adhesive single application

Eligibility

Ages Eligible for Study:	40 Years to 66 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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:
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.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650442

Locations

United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mylan Pharmaceuticals

Investigators

Principal Investigator:

Thomas S Clark, M.D.

Kendle International Inc.

More Information

Additional Information:

Mylan Pharmaceuticals Inc. - Clinical Trial Results This link exits the ClinicalTrials.gov site

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use This link exits the ClinicalTrials.gov site

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

FDA Enforcement Report Index This link exits the ClinicalTrials.gov site

Medwatch, FDA Safety Information and Adverse Event Reporting Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier:	NCT00650442 History of Changes
Other Study ID Numbers:	ESTR-02133
Study First Received:	March 30, 2008
Last Updated:	March 31, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 09, 2012