Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20.
This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (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.
Hampton
R M
RM
Texas Tech University School of Medicine, Lubbock, TX, USA.
Short
M
M
Bieber
E
E
Bouchard
C
C
Ayotte
N
N
Shangold
G
G
Fisher
A C
AC
Creasy
G W
GW
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage* / Q000009:adverse effects*; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives*; D010349:Patient Compliance; D011247:Pregnancy; D013997:Time Factors; D016896:Treatment Outcome
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C109079:norgestimate, ethinyl estradiol drug combination; C020416:norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D009640:Norethindrone