Status:

COMPLETED

Bioequivalence Study of Patches With Different Equilibration Profiles

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Conditions:

Female Contraception

Eligibility:

FEMALE

18-45 years

Phase:

PHASE1

Brief Summary

The purpose of this single center, randomized, double-blind, 2 way crossover study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.

Detailed Description

The primary objective was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system lot with a faster equilibration profile compared to currently...

Eligibility Criteria

Inclusion

  • Healthy as determined by physical and gynecologic examinations, clinical laboratory assessments, vital sign measurements, and a 12-lead electrocardiogram (ECG)

Exclusion

  • Pregnant
  • Lactating
  • Currently using hormonal contraceptive

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2004

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT00775086

Start Date

May 1 2004

End Date

August 1 2004

Last Update

June 8 2011

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