An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method
Condition: Female Contraception
Study type: Interventional
Phase: Phase 4

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 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.
    

Intervention name(s): norelgestromin; ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraception; norelgestromin; ethinyl estradiol; transdermal contraceptive patch; EVRA; ORTHO EVRA