drugset
drugset / Trial / NCT07794150

A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects

NCT07794150 ↗

Phase 1 Recruiting 250 enrolled Corium Innovations, Inc.
RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2026-08-10
Primary completion
2027-05-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.015 mg Other
Subject Estradiol Other / unclassified 0.045 mg Other

Indications

No indication recorded.