Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Estradiol Transdermal System Placebo - Alternate Adhesive |
|
| 2 | Placebo Comparator | Estradiol Transdermal System Placebo - Current Adhesive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol Transdermal System Placebo - Alternate Adhesive | Drug | single application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Transdermal Adhesion | within 30 days |
Not provided
Not provided
Inclusion Criteria:
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:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas S Clark, M.D. | Kendle International Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | United States |
Not provided
| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Estradiol Transdermal System Placebo - Current Adhesive |
| Drug |
single application |
|
| View source |