A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
A Multiple-Center Study to Evaluate the Skin Irritation and Sensitization Potential of a Test Estradiol/Levonorgestrel Transdermal Delivery System (Corium TDS)
Corium Innovations, Inc.
250 participants
Aug 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
1/2 Estradiol/Levonorgestrel Delivery System 0.045 mg per day/ 0.015 mg per day and 1/2 Climara Pro® patch 0.045 mg per day/ 0.015 mg per day will be administered simultaneously
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07794150