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drugset / Trial / NCT00258076

A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)

NCT00258076 ↗

Phase 1 Completed 53 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this study is to estimate the exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across multiple commercial lots of ORTHO EVRA® (a transdermal contraceptive patch) and to compare these data to historical hormonal exposure data from one ORTHO EVRA® clinical development lot.

Timeline

Start
2004-04
Primary completion
—
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ethinyl estradiol Small molecule 0.75 mg Other
Subject norelgestromin Unknown 6 mg Other

Indications

No indication recorded.