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. 2020 Jan 30;2:100020. doi: 10.1016/j.conx.2020.100020

Table 5.

Bleeding and spotting pattern data for women enrolled in a phase 3, multicenter, 13-cycle trial of a drospirenone 4 mg 24/4-day contraceptive regimen

Bleeding duration, days
Median
(min, max)
Spotting duration, days
Median
(min, max)
Prolonged bleeding/spotting > 9 days
n/m (%)
[95% CI]
Prolonged bleeding/spotting > 14 days
n/m (%)
[95% CI]
Women with no bleeding/spotting episodes
m (%)
Cycles 2–4
N = 609
4.0
(0, 65)
3.0
(0, 34)
132/467 (28.3)
[24.2–32.6]
55/467 (11.8)
[9.0–15.1]
142 (23.3)
Cycles 5–7
N = 448
3.0
(0, 44)
2.0
(0, 24)
57/317 (18.0)
[13.9–22.7]
20/317 (6.3)
[3.9–9.6]
131 (29.2)
Cycles 8–10
N = 376
2.0
(0, 48)
1.0
(0, 37)
57/252 (22.6)
17.6–28.3)
18/252 (7.1)
[4.3–11.1]
124 (33.0)
Cycles 11–13
N = 310
1.0
(0, 42)
1.0
(0, 31)
32/199 (16.1)
[11.3–21.9]
14/199 (7.0)
[3.9–1.5]
111 (35.8)

Full-analysis set for combined scheduled and unscheduled bleeding data; N, number of women with data available; n, number of women with prolonged bleeding/spotting in respective cycle; m, number of women with data available in respective cycle; CI, Clopper–Pearson 95% confidence interval.