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 journalArticle

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

Fingerprint

Oral Contraceptives
Metrorrhagia
Ethinyl Estradiol
Contraceptive Agents
Safety
Compliance
Multicenter Studies
Demography
ethinyl estradiol drug combination norgestimate
norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Pregnancy

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

Cite this

Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. / Hampton, Raymond Moss; Short, Marilyn; Bieber, Eric; Bouchard, Celine; Ayotte, Normand; Shangold, Gary; Fisher, Alan C.; Creasy, George W.

In: Contraception, Vol. 63, No. 6, 25.10.2001, p. 289-295.

Research output: Contribution to journalArticle

Hampton, Raymond Moss ; Short, Marilyn ; Bieber, Eric ; Bouchard, Celine ; Ayotte, Normand ; Shangold, Gary ; Fisher, Alan C. ; Creasy, George W. / Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. In: Contraception. 2001 ; Vol. 63, No. 6. pp. 289-295.
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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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AU - Creasy, George W.

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