A Study to Assess the Bioavailability and Adhesion of Estradiol/Levonorgestrel TDS in Healthy Post-Menopausal Female Participants

Phase 1 Active not recruiting 68 enrolled Corium Innovations, Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start: 2026-07-01
Primary completion: 2026-09-08
Completion: 2026-09-26

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	0.045 mg	Other
Subject	Levonorgestrel	Small molecule	0.015 mg	Other

Indications

No indication recorded.