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. Author manuscript; available in PMC: 2015 Mar 2.
Published in final edited form as: Contraception. 2012 Oct 22;87(5):685–700. doi: 10.1016/j.contraception.2012.08.035

Table 4.

Evidence regarding risk of ovulation after deliberate dosing errors during weeks not adjacent to the patch-free interval

Reference, sources of support Study population Study design/intervention Outcome Results Strengths Weaknesses Quality
Abrams et al., 2001 [26]
  RW Johnson Pharmaceutical Research Institute		 12 women, ages 18–44, 1 center, USA PK study, patch users followed for 2 patch applications: the 1st for 7 days (proper dosing) and the 2nd for 10 days (3-day dosing error); serum levels of EE and progestin norelgestromin drawn prior to patch application, and at specific times on days 1–3 and 6–19 Serum levels of EE and progestin norelgestromin Mean serum concentrations of EE and progestin norelgestromin remained within reference ranges (25–75 pg/mL and 0.6–1.2 ng/mL, respectively) during 7-day patch wear period and when patch deliberately worn for 10 days 3-day dosing error).
  • -

    Women had history of regular cycles

  • -

    All patches adhered during study period
  • -

    Small sample

  • -

    Single center

 a
Pierson et al., 2003 [24]
  Johnson & Johnson Pharmaceutical Research & Development, LLC		 124 women (patch group n=52), ages 18–35 years, 12 centers, USA and Canada RCT, 5 groups (2 described here). Correct dosing in cycles 1, 2, 3 and 5. Dosing error in cycle 4, a 10-day cycle: patch group 1 wore one patch for 10 consecutive days; patch group 2 had correct dosing on days 1–7 and received no drug on days 8–10. Ovarian ultrasound performed prestudy and during cycles 1–5. Blood serum levels of EE, LH, FSH and progesterone measured Ovulation: disappearance of a large periovulatory follicle observed via ultrasound and progesterone levels ≥3 ng/mL within 7–10 days after follicle disappearance After dosing errors (cycle 5), mean maximum follicular size between groups 1 and 2 did not significantly differ (7.1 mm versus 6.8 mm, respectively). Ovulation for patch groups combined (data not reported for each group separately) for cycles 1, 2 and 3 (correct dosing) were 0/49 (0%), 1/48 (2%) and 0/48 (0%), respectively. Ovulation was 1/43 (2%) after dosing errors (cycle 5)
  • -

    Women had history of regular cycles

  • -

    Moderate sample of patch users

  • -

    Definition of ovulation

  • -

    Multiple centers
  • -

    Randomization procedures not described

 I, fair, indirect

Abbreviation: PK=pharmacokinetic study.

a

Quality of pharmacokinetic studies not assessed.