Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol

Katherine D. LaGuardia, Gary Shangold, Alan Fisher, Andrew Friedman, Michael Kafrissen

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN® (NGM 180/215/250 μg/EE 35 μg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN® Lo (NGM 180/215/250 μg/EE 25 μg), one of three cyclophasic regimens (NGM cycling 180-250 μg/EE 35 μg or 25 μg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. Presumed ovulation (serum progesterone levels ≥3 ng/mL during Days 19-21 of Cycle 3), occurred in 0/41 (0%) subjects on ORTHO TRI-CYCLEN Lo and 3/43 (7%) subjects on ORTHO TRI-CYCLEN. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. The mean number of days of BBS/cycle for ORTHO TRI-CYCLEN Lo and ORTHO TRI-CYCLEN was 3.7 and 3.1, respectively, for those subjects with such bleeding. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.

Original languageEnglish
Pages (from-to)431-437
Number of pages7
JournalContraception
Volume67
Issue number6
DOIs
StatePublished - 1 Jun 2003
Externally publishedYes

Keywords

  • Cycle control
  • Ethinyl estradiol
  • Norgestimate
  • Ortho Tri-Cyclen®
  • Ortho Tri-Cyclen® Lo
  • Ovulation suppression

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