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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Estradiol Transdermal System Placebo - Current Adhesive; Drug: Estradiol Transdermal System Placebo - Alternate Adhesive

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650442

ESTR-02133

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: Female

Ages: 40 to 66 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

39 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Estradiol Transdermal System Placebo - Alternate Adhesive

Treatment:

Drug: Estradiol Transdermal System Placebo - Alternate Adhesive

2

Placebo Comparator group

Description:

Estradiol Transdermal System Placebo - Current Adhesive

Treatment:

Drug: Estradiol Transdermal System Placebo - Current Adhesive