A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
brief summary
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.
detailed description
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Estradiol/Levonorgestrel transdermal system in comparison to Climara Pro® transdermal patch in healthy postmenopausal women. The study will consist of a 5 week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales specified within FDA Product Specific Guidance.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
official title
A Multiple-Center Study to Evaluate the Skin Irritation and Sensitization Potential of a Test Estradiol/Levonorgestrel Transdermal Delivery System (Corium TDS)