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

NCT07794150 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-08-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Estradiol/Levonorgestrel Transdermal System

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

Sponsors & Collaborators

  • Corium Innovations, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794150 on ClinicalTrials.gov