Paloma Lobo Abascal1, Vesna Luzar-Stiffler2, Silvana Giljanovic3, Brandon Howard4, Herman Weiss5, James Trussell6. 1. a * Hospital Universitario Infanta Sofía, San Sebastián de los Reyes , Madrid , Spain. 2. b CAIR Center - The House of Statistics , Zagreb , Croatia. 3. c Medical Affairs EU, Pliva Croatia, Teva Group , Zagreb , Croatia. 4. d Teva Global Medical Affairs , Frazer , PA , USA. 5. e Teva Global Medical Affairs , Petach Tikva , Israel. 6. f Office of Population Research, Princeton University , Princeton , NJ , USA.
Abstract
BACKGROUND: Regulatory agencies in the United States (US) and Europe differ in requirements for defining pregnancies after the last dose of oral contraceptive, sometimes resulting in discrepant Pearl Indices (PIs) for the same product despite identical clinical data. This brief report highlights one such example, a 91-day extended-regimen combined oral contraceptive (COC). METHODS: The US- and European-based PI methodologies were compared for a 91-day extended-regimen COC consisting of 84 days of active levonorgestrel/EE 150 μg/30 μg tablets, followed by seven days of EE 10 μg tablets in place of placebo. CONCLUSIONS: At the times of approval of the 91-day extended-regimen COC in the US and Europe, the requirements for defining 'on-treatment' pregnancies differed (14-day vs. 2-day rule, respectively). This difference resulted in a higher PI in the US- vs. European-based calculation (1.34 and 0.76, respectively). The differences in the PI should not be interpreted as the extended-regimen COC being less effective in preventing pregnancy in the US compared with Europe.
BACKGROUND: Regulatory agencies in the United States (US) and Europe differ in requirements for defining pregnancies after the last dose of oral contraceptive, sometimes resulting in discrepant Pearl Indices (PIs) for the same product despite identical clinical data. This brief report highlights one such example, a 91-day extended-regimen combined oral contraceptive (COC). METHODS: The US- and European-based PI methodologies were compared for a 91-day extended-regimen COC consisting of 84 days of active levonorgestrel/EE 150 μg/30 μg tablets, followed by seven days of EE 10 μg tablets in place of placebo. CONCLUSIONS: At the times of approval of the 91-day extended-regimen COC in the US and Europe, the requirements for defining 'on-treatment' pregnancies differed (14-day vs. 2-day rule, respectively). This difference resulted in a higher PI in the US- vs. European-based calculation (1.34 and 0.76, respectively). The differences in the PI should not be interpreted as the extended-regimen COC being less effective in preventing pregnancy in the US compared with Europe.
Entities:
Keywords:
Combined oral contraceptive; Extended-regimen; Pearl Index
Authors: Robin Kroll; Larry Seidman; Nancy Ricciotti; Brandon Howard; Herman Weiss Journal: Eur J Contracept Reprod Health Care Date: 2014-12-19 Impact factor: 1.848
Authors: David F Archer; Ruth B Merkatz; Luis Bahamondes; Carolyn L Westhoff; Philip Darney; Dan Apter; Jeffrey T Jensen; Vivian Brache; Anita L Nelson; Erika Banks; György Bártfai; David J Portman; Marlena Plagianos; Clint Dart; Narender Kumar; George W Creasy; Regine Sitruk-Ware; Diana L Blithe Journal: Lancet Glob Health Date: 2019-06-20 Impact factor: 26.763