OBJECTIVE: The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated. STUDY DESIGN: In this randomized study, 610 subjects received10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week. RESULTS: The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P <.001). All regimens had safety profiles typical of oral contraceptives. CONCLUSION: The 20-cm(2) patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance.
RCT Entities:
OBJECTIVE: The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated. STUDY DESIGN: In this randomized study, 610 subjects received 10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week. RESULTS: The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P <.001). All regimens had safety profiles typical of oral contraceptives. CONCLUSION: The 20-cm(2) patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance.
Authors: Robby Nieuwlaat; Nancy Wilczynski; Tamara Navarro; Nicholas Hobson; Rebecca Jeffery; Arun Keepanasseril; Thomas Agoritsas; Niraj Mistry; Alfonso Iorio; Susan Jack; Bhairavi Sivaramalingam; Emma Iserman; Reem A Mustafa; Dawn Jedraszewski; Chris Cotoi; R Brian Haynes Journal: Cochrane Database Syst Rev Date: 2014-11-20
Authors: Jesus Hernandez-Juarez; Ethel A Garcia-Latorre; Manuel Moreno-Hernandez; Jose Fernando Moran-Perez; Miguel Angel Rodriguez-Escobedo; Gerardo Cogque-Hernandez; Rubén Julián-Nacer; Xochitl Hernandez-Giron; Rosalia Palafox-Gomez; Irma Isordia-Salas; Abraham Majluf-Cruz Journal: Reprod Health Date: 2014-04-26 Impact factor: 3.223