Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20

Raymond Moss Hampton, Marilyn Short, Eric Bieber, Celine Bouchard, Normand Ayotte, Gary Shangold, Alan C. Fisher, George W. Creasy

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)289-295
Number of pages7
JournalContraception
Volume63
Issue number6
DOIs
StatePublished - Oct 25 2001

Keywords

  • Compliance
  • Cycle control
  • Ethinyl estradiol
  • Loestrin Fe 1/ 20
  • Norethindrone acetate
  • Norgestimate
  • Ortho Tri-Cyclen Lo
  • Safety

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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