Status:
COMPLETED
An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Female Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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.
Detailed Description
This was a multicentre, single-arm, open-label study. The objective of this phase IV study was to document the experience of women with the transdermal contraceptive patch (a weekly contraceptive patc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00653016
Start Date
October 1 2002
End Date
August 1 2003
Last Update
March 26 2010
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