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 language | English |
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Pages (from-to) | 431-437 |
Number of pages | 7 |
Journal | Contraception |
Volume | 67 |
Issue number | 6 |
DOIs | |
State | Published - 1 Jun 2003 |
Externally published | Yes |
Keywords
- Cycle control
- Ethinyl estradiol
- Norgestimate
- Ortho Tri-Cyclen®
- Ortho Tri-Cyclen® Lo
- Ovulation suppression