Phase 1Active, not recruiting
A Study to Assess the Bioavailability and Adhesion of Estradiol/Levonorgestrel TDS in Healthy Post-Menopausal Female Participants
A Study to Compare the Bioequivalence and Adhesion Between a Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg Per Day/0.015 mg Per Day) (Corium TDS) and Reference Climara Pro® at the Same Strength (0.045 mg Per Day / 0.015 mg Per Day) for Seven Days in Post-menopausal Female Participants
- Sponsor
- Corium Innovations, Inc. (Industry)
- Enrolment
- 68 enrolled
- Conditions
- Healthy Female Participants; Postmenopause
- Interventions
- Test Estradiol/Levonorgestrel Transdermal Delivery System; Climara Pro® (Estradiol/Levonorgestrel Transdermal System)
- Ages
- adults, older adults
- Registry
- NCT07851649
From the registry
The purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), following a single 7-day application in healthy postmenopausal female participants. The study will also evaluate the safety and tolerability of the test and reference patches.
Primary outcomes
- Maximum Plasma Concentration (Cmax) of Baseline-Corrected Estradiol
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Baseline-Corrected Estradiol
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Baseline-Corrected Estradiol
- Maximum Plasma Concentration (Cmax) of Levonorgestrel