NCT00775086

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2004

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

June 19, 2008

Last Update Submit

June 6, 2011

Conditions

Female Contraception

Keywords

ORTHO EVRAcontraceptionNGMNcontraceptive patchbioequivalenceEEnorelgestrominethinyl estradiol

Outcome Measures

Primary Outcomes (1)

  • The faster equilibrating patches were bioequivalent to the currently marketed patch

Secondary Outcomes (1)

  • Safe and well tolerated

Interventions

norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Lactating
  • Currently using hormonal contraceptive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

norelgestrominEthinyl Estradiol

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2008

First Posted

October 17, 2008

Study Start

May 1, 2004

Study Completion

August 1, 2004

Last Updated

June 8, 2011

Record last verified: 2010-04