Clinical trials

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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 250
Trial details
Phase: Phase 1Age: 40-75Biological sex: FemaleType: InterventionalSponsor: Corium Innovations, Inc.Updated: Sep 10, 2026Locations: 2
Eligibility criteria

At least 12 months natural spontaneous amenorrhea; or [+10]

Male participants. [+33]