NCT00236769

Brief Summary

The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,751

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 1997

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

November 1, 1997

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1999

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

First QC Date

October 7, 2005

Last Update Submit

November 15, 2010

Conditions

ContraceptionFemale Contraception

Keywords

contraceptiontransdermal contraceptionhormonal, steroidal contraceptionethinyl estradiolprogesterone

Outcome Measures

Primary Outcomes (1)

  • Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.

Secondary Outcomes (1)

  • Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.

Interventions

norelgestromin + ethinyl estradiolDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy women with regular menstrual cycles
  • sexually active and at risk of pregnancy
  • nonpregnant
  • acceptable body mass index (BMI)
  • last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
  • sitting BP\<140mmHg/\<90mmHg
  • normal menstrual cycle since removal of IUD or norplant
  • agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
  • agree not to use other systemic steroid medication

You may not qualify if:

  • Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
  • cerebral vascular or coronary artery disease, hypertension, or severe migraines
  • liver tumor resulting from estrogen-containing products
  • diabetes mellitus
  • cholestatic jaundice, liver or renal disease
  • abnormal PAP smear
  • thyroid disorder
  • dermal hypersensitivity
  • carcinoma of breast, endometrium or other estrogen-dependent neoplasia
  • substance abuse
  • received experimental drug within prior 30 days
  • smoking women over 35 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC, Creasy GW; ORTHO EVRA/EVRA 002 Study Group. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol. 2001 Nov;98(5 Pt 1):799-805. doi: 10.1016/s0029-7844(01)01534-4.

    PMID: 11704172RESULT

  • Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002 Feb;77(2 Suppl 2):S13-8. doi: 10.1016/s0015-0282(01)03275-7.

    PMID: 11849631RESULT

  • Zacur HA, Hedon B, Mansour D, Shangold GA, Fisher AC, Creasy GW. Integrated summary of Ortho Evra/Evra contraceptive patch adhesion in varied climates and conditions. Fertil Steril. 2002 Feb;77(2 Suppl 2):S32-5. doi: 10.1016/s0015-0282(01)03262-9.

    PMID: 11849634RESULT

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 & Development, L.L. C. Clinical Trial

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

November 1, 1997

Study Completion

October 1, 1999

Last Updated

November 17, 2010

Record last verified: 2010-11