The purpose of this study is to compare
bleeding patterns and acceptability of a
contraceptive regimen of combined 20 microg
ethinyl estradiol/100 microg
levonorgestrel taken with and without a
hormone-free interval. Thirty-two women desiring oral
contraception were randomized to six 28-day cycles (standard group) or 168 days without a pill-free interval (continuous group). Participants kept a daily
bleeding calendar documenting
bleeding events (none,
spotting or required sanitary protection) and side effects (
headache,
nausea, breast tenderness, depression,
premenstrual syndrome and bloating). Primary outcome was number of
bleeding days. Secondary outcomes included
bleeding days requiring sanitary protection,
amenorrhea, patient acceptability of
bleeding patterns, method satisfaction and affective side effects. There were no differences in the baseline characteristics of the two groups. Although total
bleeding days were fewer in the continuous group (mean = 25.9 vs. 34.9 days), this result did not reach statistical significance. However, women in the continuous group reported significantly fewer
bleeding days that required protection (18.4 vs. 33.8 days, p < 0.01), and were more likely to have
amenorrhea. Although both groups reported a high level of satisfaction with
bleeding patterns and side effect profiles, women in the continuous group reported significantly fewer days of bloating (0.7 vs. 11.1 days, p = 0.04), and
menstrual pain (1.9 vs. 13.3 days, p < 0.01). Continuous use of 20 microg
ethinyl estradiol/100 microg
levonorgestrel is associated with less
bleeding requiring protection, and more
amenorrhea than standard administration. Taken with or without a
hormone-free interval, this
oral contraceptive formulation is highly acceptable with regard to
bleeding patterns and side effect profile. The continuous group had fewer light and moderate
bleeding days, less bloating and
menstrual pain. For patients who are seeking these results, this method may be more desirable.