NCT00697307

Brief Summary

The purpose of this 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
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2003

Shorter than P25 for all trials

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

March 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

June 8, 2011

Status Verified

March 1, 2010

First QC Date

June 5, 2008

Last Update Submit

June 6, 2011

Conditions

Female Contraception

Keywords

bioequivalencecontraceptioncontraceptive patchORTHO EVRAnorelgestrominNGMNethinyl estradiolEE

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

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 13, 2008

Study Start

March 1, 2003

Study Completion

July 1, 2003

Last Updated

June 8, 2011

Record last verified: 2010-03