Wyeth’s Lybrel, the first continuous-use oral contraceptive, has been approved. The tablet comes in a 28-day pack with low-dose combination tablets containing 90 mcg of a progestin (generic levonorgestrel) and 20 mcg of an estrogen (ethinyl estradiol).
With the traditional contraceptives, patients take the medication for 21 days, then stop for seven days; the placebo or pill-free time intervals last four to seven days to simulate a menstrual cycle. The Lybrel regimen does not include the week off from the placebo tablets.
Women who use Lybrel do not have a scheduled menstrual period but may experience unplanned breakthrough bleeding or spotting; this effect usually tapers off within the first year of use.
The safety and efficacy of Lybrel as a contraceptive method were supported by two one-year clinical studies enrolling more than 2,400 women 18 to 49 years of age.