TY - JOUR
T1 - Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20
AU - Hampton, Raymond Moss
AU - Short, Marilyn
AU - Bieber, Eric
AU - Bouchard, Celine
AU - Ayotte, Normand
AU - Shangold, Gary
AU - Fisher, Alan C.
AU - Creasy, George W.
PY - 2001
Y1 - 2001
N2 - This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 μg)/ethinyl estradiol 25 μg regimen (Ortho Tri-Cyclen Lo) (n=1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 μg (Loestrin Fe 1/20) (n=1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. Breakthrough bleeding and spotting was reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.
AB - This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 μg)/ethinyl estradiol 25 μg regimen (Ortho Tri-Cyclen Lo) (n=1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 μg (Loestrin Fe 1/20) (n=1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. Breakthrough bleeding and spotting was reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.
KW - Compliance
KW - Cycle control
KW - Ethinyl estradiol
KW - Loestrin Fe 1/ 20
KW - Norethindrone acetate
KW - Norgestimate
KW - Ortho Tri-Cyclen Lo
KW - Safety
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U2 - 10.1016/S0010-7824(01)00214-1
DO - 10.1016/S0010-7824(01)00214-1
M3 - Article
C2 - 11672549
AN - SCOPUS:0034799821
SN - 0010-7824
VL - 63
SP - 289
EP - 295
JO - Contraception
JF - Contraception
IS - 6
ER -