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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Corium Innovations, Inc.
Study ID
NCT07794150
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Estradiol/Levonorgestrel Transdermal System — DRUG
    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

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Aug 10, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 1/2 patch Estradiol/Levonorgestrel TDS on left buttock, 1/2 patch Climara Pro® TDS on right buttock
  • Other: 1/2 patch Estradiol/Levonorgestrel TDS on right buttock, 1/2 patch Climara Pro® TDS on left buttock

Primary Outcome Measure

Mean Irritation Score (MIS) for the Test and Reference Patches During the 21-Day Continuous Application Period [ Time Frame: From Day 1 through Day 22 (21-day continuous application period; assessments 30 minutes [+10 minutes] after patch removal on Days 8, 15, and 22) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Novum Pharmaceutical Research ServicesLas VegasNevada89121-

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Novum Pharmaceutical Research Services· Las Vegas, NV

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