A Phase 4 interventional study of norelgestromin; ethinyl estradiol in Female Contraception, sponsored by Janssen-Ortho Inc., Canada. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2010-03-26.
Sponsored by Janssen-Ortho Inc., Canada · Phase 4, Interventional, and Treatment
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.
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 patch delivering 150 mg norelgestromin/20 mg ethinyl estradiol daily) over a period of 9 cycles, compared to their previous contraceptive method. An open-label, multicentre, descriptive cohort study of 392 women requiring contraception were enrolled to receive the patch for nine cycles. A single treatment cycle consisted of three consecutive 7-day patch applications followed by one patch-free week. At the final visit, overall satisfaction and preference for the patch was rated compared to the previous contraceptive method.) The primary outcomes were treatment preference and overall satisfaction. Compliance, contraceptive efficacy, adhesion, and safety measures were secondary outcomes. Study participants were scheduled to receive the contraceptive patch for up to nine consecutive treatment cycles. Participants attended the clinic for 3 study visits: baseline/screening, Day 28 of Cycle 3 and Day 28 of Cycle 9 (or at early termination). A telephone interview was conducted on Day 28 of Cycle 6. Approximately 400 women were to be enrolled into the study and receive the transdermal contraceptive patch. Patients were recruited using ethics approved advertisements, in addition to investigators approaching patients presenting for routine well-woman checks. Participants who met all of the eligibility criteria were instructed to apply the first patch on the first day of their next menses (or 13 weeks following the last medroxyprogesterone acetate injection) and to wear this patch for seven days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day. Only one patch was to be worn at a time. Patches could be applied to the buttocks, abdomen, upper outer arm, or upper torso (excluding breasts) and participants were instructed to apply new patches to a different site. Patches were to adhere on their own; no supplemental tape or adhesive was permitted. If a patch partially detached, participants could reapply it; however, patches that completely detached were to be replaced immediately and the replacement patch would be worn for the remainder of that week. Eligible patients were instructed to apply the 1st patch on the first day of their next menses (or 13 weeks following last medroxyprogesterone acetate injection) and to wear this patch for 7days. They were then instructed to apply a new patch for weeks 2 and 3, and then be patch-free for week 4. Applying a new patch on the day after week 4 ended started a new cycle. All patches were to be applied/changed on the same day of the week and at approximately the same time of day.
Janssen-Ortho Inc., Canada is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
No study locations are listed for this record.
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Janssen-Ortho Inc., Canada