drugset
drugset / Trial / NCT04017195

A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women

NCT04017195 ↗

Phase 1 Completed 68 enrolled Janssen Research & Development, LLC
RandomizedCrossoverDouble-blindOther

Summary

The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin \[NGMN\] and ethinyl estradiol \[EE\]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.

Timeline

Start
2019-07-12
Primary completion
2019-12-13
Completion
2019-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject ethinyl estradiol Small molecule — Other
Subject ethinyl estradiol Small molecule — —
Subject norelgestromin Unknown — Other
Subject norelgestromin Unknown — —

Indications

No indication recorded.