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

NCT00650442 | Completed Phase 1

• 1 other identifier: ESTR-02133
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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 transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Transdermal Adhesion

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Estradiol Transdermal System Placebo - Alternate Adhesive

Drug: Estradiol Transdermal System Placebo - Alternate Adhesive

2

PLACEBO COMPARATOR

Estradiol Transdermal System Placebo - Current Adhesive

Drug: Estradiol Transdermal System Placebo - Current Adhesive

Interventions

Estradiol Transdermal System Placebo - Alternate Adhesive DRUG

single application

1

Estradiol Transdermal System Placebo - Current Adhesive DRUG

single application

2

Eligibility Criteria

• Age: 40 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

Study Officials

• Thomas S Clark, M.D.

  Kendle International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: January 1, 2003
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: April 1, 2008

Record last verified: 2008-03

Locations

US (1)