NCT00653016

Brief Summary

The purpose of this study is to document the experience of transdermal contraceptive patch over a period of 9 cycles, compared to their previous contraceptive method.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
405

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_4

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

October 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

March 26, 2010

Status Verified

March 1, 2010

First QC Date

April 1, 2008

Last Update Submit

March 25, 2010

Conditions

Female Contraception

Keywords

Contraceptionnorelgestrominethinyl estradioltransdermal contraceptive patchEVRAORTHO EVRA

Outcome Measures

Primary Outcomes (1)

  • Final visit - preference for patch vs. previous method, identify main reason for preference; satisfaction questionnaire with the previous contraceptive method at baseline and with the patch at the end of cycles 3, 6, 9 or early termination

Secondary Outcomes (1)

  • ongoing compliance based on dosing data recorded in diary cards; efficacy using the Pearl Index; patch adhesion using diary cards; adverse events at each visit, vital signs, body weigh changes, physical and gynaecological exams

Interventions

norelgestromin; ethinyl estradiolDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy females, who were sexually active and at risk of pregnancy were eligible to participate in this study provided that they had regular menses occurring every 25 to 35 days (except for those women using medroxyprogesterone acetate)
  • women who were using one of the following methods of contraception as their primary method in the 3 months prior to admission: oral contraceptive, intrauterine device, medroxyprogesterone acetate injection, double-barrier method consisting of condoms and spermicidal foam or gel, or a diaphragm and spermicidal foam or gel
  • study participants had to have a normal Pap smear within the previous 12 months
  • a negative urine pregnancy test at admission
  • have a systolic/diastolic blood pressure \<= 140/90 mm Hg
  • be within 35% of acceptable body mass index (upper limit of 32.4)
  • be willing to switch their current method of contraception
  • and agree not to use any other steroid hormonal therapy other than topical corticosteroids or inhaled corticosteroids for asthma, during the course of the study.

You may not qualify if:

  • History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, e.g., deep vein thrombophlebitis, thromboembolic disorders, cerebral vascular or coronary artery disease, etc.
  • Additionally, participants who were menopausal
  • had skin conditions resulting in oily, irritated or damaged skin at all potential application sites
  • Had a history or presence of dermal hypersensitivity
  • The presently used contraceptive method were any of condoms alone, abstinence, withdrawal, or a rhythm method
  • Had received medroxyprogesterone acetate injection \<=12 weeks prior to enrolment
  • had a history of alcohol or substance abuse within 12 months of enrolment
  • had received any experimental drug or device within 30 days of enrolment
  • Had used barbiturates, antiepileptics, rifampin, griseofulvin, or other hepatic enzyme inducing drugs within 30 days of enrolment
  • Chronic systemic antibiotic use
  • Had an uncontrolled thyroid disorder
  • Were smokers over the age of 35
  • Had Pap smear evidence of atypical squamous cells or adenocarcinoma or other malignancy
  • Had a desire to conceive in the subsequent 9 months of enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Weisberg F, Bouchard C, Moreau M, Audet MC, Mawdsley S, Dattani D, Dinniwell J, Horbay GL; NRGEEP-CON-401 Study Group. Preference for and satisfaction of Canadian women with the transdermal contraceptive patch versus previous contraceptive method: an open-label, multicentre study. J Obstet Gynaecol Can. 2005 Apr;27(4):350-9. doi: 10.1016/s1701-2163(16)30462-5.

    PMID: 15937609RESULT

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

  • Janssen-Ortho Inc. Clinical Trial

    Janssen-Ortho Inc., Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

October 1, 2002

Study Completion

August 1, 2003

Last Updated

March 26, 2010

Record last verified: 2010-03