Table 1. Baseline demographics of women randomized in studies 1 and 2, shown as mean ± SD (range).
| Study 1 | Sequence P–M–E* n = 13 |
Sequence M–P–E†
n = 12 |
Total n = 25 |
|
|---|---|---|---|---|
| Age, years | 27.2 ± 6.1 (19 – 37) |
29.2 ± 7.0 (19 – 39) |
28.1 ± 6.5 (19 – 39) |
|
| Weight, kg | 68.3 ± 10.4 (57.4 – 88.2) |
64.7 ± 9.3 (49.5 – 81.4) |
66.6 ± 9.8 (49.5 – 88.2) |
|
| Height, cm | 167.6 ± 5.7 (155 – 177) |
164.8 ± 7.1 (148 – 175) |
166.2 ± 6.5 (148 – 177) |
|
| BMI, kg/m2 | 24.3 ± 3.1 (19.9 – 29.8) |
23.8 ± 2.8 (19.6 – 30.3) |
24.1 ± 2.9 (19.6 – 30.3) |
|
| Study 2 | EE/GSD patch†
n = 200 |
EE/NGMN patch††
n = 198 |
||
| Age, years | 24.9 ± 4.3 (18 – 35) |
24.5 ± 4.6 (18 – 35) |
||
| Weight, kg | 61.2 ± 9.2 (45 – 89) |
63.3 ± 9.0 (42 – 89) |
||
| Height, cm | 167.3 ± 5.9 (152 – 185) |
167.9 ± 5.9 (150 – 184) |
||
| BMI, kg/m2 | 21.8 ± 2.8 (17 – 30) |
22.4 ± 2.8 (17 – 30) |
||
*Sequence P–M–E = treatment P: 0.55 mg EE + 2.1 mg GSD per patch (4 × 7-day wearing period); treatment M: 0.02 mg EE + 0.075 mg GSD per pill (21-day, oral, once daily); treatment E: 0.55 mg EE + 2.1 mg GSD per patch (2 × 7-day, followed by 1 × 10-day, wearing period); †Sequence M–P–E = treatment M: 0.02 mg EE + 0.075 mg GSD per pill (21-day, oral, once daily); treatment P: 0.55 mg EE + 2.1 mg GSD per patch (4 × 7-day wearing period); treatment E: 0.55 mg EE + 2.1 mg GSD per patch (2 × 7-day, followed by 1 × 10-day, wearing period); †0.55 mg EE/2.1 mg GSD; ††0.6 mg EE/6 mg NGMN; the only commercially available patch in study countries. BMI = body mass index; EE = ethinyl estradiol; GSD = gestodene; SD = standard deviation.