An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method
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ClinicalTrials.gov Identifier: NCT00653016 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : March 26, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Contraception | Drug: norelgestromin; ethinyl estradiol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 405 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Multicentre Study to Evaluate Patient Satisfaction and Preference for the EVRA Transdermal Contraceptive System Compared to Previously Used Contraceptive Method. |
Study Start Date : | October 2002 |
Actual Study Completion Date : | August 2003 |

- 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
- 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

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653016
Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
ClinicalTrials.gov Identifier: | NCT00653016 |
Other Study ID Numbers: |
CR002908 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | March 26, 2010 |
Last Verified: | March 2010 |
Contraception norelgestromin ethinyl estradiol |
transdermal contraceptive patch EVRA ORTHO EVRA |
Norelgestromin Estradiol Ethinyl Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Combined Contraceptives, Oral |