Adherence with ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen supported by the use of a digital tablet dispenser with or without acoustic alarm: an open-label, randomized, multicenter study

Figures & data

Figure 1 The adherence-aiding dispenser.

Note: A prototype of the dispenser was used in the clinical study.

Figure 2 Disposition of subjects (FAS).

Notes: Group A (activated acoustic alarm) and group B (deactivated acoustic alarm).
Abbreviation: FAS, full analysis set.

Table 1 Baseline demographics and clinical characteristics (full analysis set)

	Group A (activated acoustic alarm)	Group B (deactivate acoustic alarm)	Total
Mean age (years) (SD)	25.3 (4.3)	25.7 (4.0)	25.5 (4.1)
Mean BMI (SD)	22.7 (2.9)	22.4 (3.1)	22.5 (3.0)
Caucasian, N (%)	215 (86.0)	216 (86.7)	431 (86.4)
Smoking
Never, N (%)	146 (58.4)	144 (57.8)	290 (58.1)
Former, N (%)	30 (12.0)	30 (12.0)	60 (12.0)
Current, N (%)	74 (29.6)	75 (30.1)	149 (29.9)
Race, N (%)
White	215 (86)	216 (86.7)	431 (86.4)
Black/African	2 (0.8)	0	2 (0.4)
American Asian	0	1 (0.4)	1 (0.2)
Missing/not reported	33 (13.2)	32 (12.4)	65 (12.8)
Educational level, N (%)
Elementary	5 (2)	5 (2)	10 (2)
Secondary	109 (43.6)	95 (38.2)	204 (40.9)
College/university	136 (54.4)	149 (59.8)	285 (57.1)
Alcohol consumption, N (%)
Abstinent	74 (29.6)	76 (30.5)	150 (30.1)
Light	173 (69.2)	165 (66.3)	338 (67.7)
Moderate	3 (1.2)	8 (3.2)	11 (2.2)
Number of pregnancies, N (%)
0	193 (77.2)	184 (73.9)	377 (75.6)
≥1	57 (22.8)	65 (26.1)	122 (24.4)
Number of births, N (%)
0	205 (82.0%)	198 (79.5%)	403 (80.8)
≥1	45 (18.0)	51 (20.5)	96 (19.2)
Previous contraception, N (%)
None	12 (4.8)	12 (4.8)	24 (4.8)
Oral	205 (82.0)	213 (85.5)	418 (83.8)
Vaginal	4 (1.6)	3 (1.2)	7 (1.4)
Transdermal	1 (0.4)	1 (0.4)	2 (0.4)
Barrier	28 (11.2)	19 (7.6)	47 (9.4)
Implant	0	1 (0.4)	1 (0.2)

Note: Totals may not add up to 100% due to rounding.

Abbreviations: BMI, body mass index; SD, standard deviation.

Figure 3 Box and whisker plot for number of missed pills per year in group A (activated acoustic alarm) and group B (deactivated acoustic alarm) according to dispenser (A) and diary card data (full analysis set) (B).

Notes: Boxes range from Q1 to median (light) and from median to Q3 (dark) and whiskers range from minimum to maximum (cutoff at 30). If no box is displayed then Q3 is zero.
Abbreviation: Q, quartile.

Figure 4 Proportion of women with missed pills over 1 year in group A (acoustic alarm activated) and group B (acoustic alarm deactivated) (full analysis set).

Figure 5 Mean (standard deviation [SD]) cycle length (A) and mean (SD) number of days with bleeding (excluding spotting), and bleeding and spotting combined over 1 year by country (B) (diary card data for pooled treatment groups; full analysis set).

Notes: Cycle length includes the 4-day break. The last cycle for each subject was calculated including a 4-day break.

Figure 6 Mean number (standard deviation) of bleeding, spotting, and bleeding/spotting days per 90-day reference period over 1 year of ethinylestradiol/drospirenone_Flex use in the two groups (reference periods 1–4) (full analysis set).

Figure 7 Proportion of women with intracyclic bleeding during the first 24 days of each intake cycle in groups A and B (full analysis set).