Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20 |
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Authors: | Raymond Moss Hampton Marilyn Short Eric Bieber Celine Bouchard Normand Ayotte Gary Shangold Alan C. Fisher George W. Creasy |
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Affiliation: | a Texas Tech University School of Medicine, Lubbock, TX, USA b Johns Hopkins Medical Services, Baltimore, MD, USA c University of Chicago, Chicago, IL, USA d Clinic Externe, Winnepeg, Canada e Clinique de Gynecologie, Shawinigan, Canada f The R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ, USA |
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Abstract: | 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. |
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Keywords: | Ortho Tri-Cyclen Lo Loestrin Fe 1/ 20 Cycle control Compliance Safety Norgestimate Ethinyl estradiol Norethindrone acetate |
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