Adherence to a flexible extended regimen for oral hormonal contraception provided in blister packaging compared with an adherence-supporting digital tablet dispenser: historical comparison of data from two clinical studies

Figures & data

Figure 1 Flexible extended regimen of EE 20 μg/drospirenone 3 mg (YAZ^® Flex).

Notes: The regimen requires a minimum of 24 days of continuous pill intake (mandatory phase), after which women decide when to take the 4-day pill-free break any time between days 25 and 120 (flexible phase). ^aWomen were advised to take a 4-day pill-free break if three consecutive days of bleeding or spotting occurred.
Abbreviation: EE, ethinylestradiol.

Table 1 Baseline demographics and clinical characteristics

Characteristics	Study 1: blister packaging (adherence data from paper diary)^Citation8	Study 2: dispenser device (adherence data from device and paper diary)^Citation10
	Diary card (n=642)	Activated acoustic alarm (n=250)	Deactivated acoustic alarm (n=249)
Mean (SD): age, years	24.8 (4.4)	25.3 (4.3)	25.7 (4.0)
Mean (SD): height, cm	167.2 (6.3)	N/A	N/A
Mean (SD): BMI, kg/m^2	22.5 (2.7)	22.7 (2.9)	22.4 (3.10)
Caucasian ethnicity, n (%)	636 (99.1)	215 (86.0)	216 (86.7)
Smoking status, n (%)
Never	N/A	146 (58.4)	144 (57.8)
Former	N/A	30 (12.0)	30 (12.0)
Current	205 (31.9)	74 (29.6)	75 (30.1)
Educational level, n (%)
Elementary	34 (5.2)	5 (2.0)	5 (2.0)
Secondary	289 (45.0)	109 (43.6)	95 (38.2)
College/university	319 (49.7)	136 (54.4)	149 (59.8)
Alcohol consumption, n (%)
Abstinent	N/A	74 (29.6)	76 (30.5)
Light	N/A	173 (69.2)	165 (66.3)
Moderate	N/A	3 (1.2)	8 (3.2)
Number of pregnancies, n (%)
0	N/A	193 (77.2)	184 (73.9)
≥1	N/A	57 (22.8)	65 (26.1)
Number of births, n (%)
0	513 (79.9)	205 (82.0)	198 (79.5)
≥1	129 (20.1)	45 (18.0)	51 (20.5)
Previous contraception, n (%)
COCs	538 (83.8)	205 (82.0)	213 (85.5)
Condoms	77 (12.0)	28 (11.2)	19 (7.6)
None	17 (2.6)	12 (4.8)	12 (4.8)
Othera	10 (1.6)	5 (2.0)	5 (2.0)

Notes: Data indicate the values obtained from all women who received at least one dose of study medication and had at least one clinical observation after the administration of study medication.

a Other includes vaginal, transdermal, and implant. Adapted by permission from BMJ Publishing Group Ltd. Contraceptive efficacy and tolerability of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen: an open-label, multi centre, randomised, controlled study, Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J, Volume 38(2), Pages 73–83, Copyright 2012.

Abbreviations: BMI, body mass index; COC, combined oral contraceptives; N/A, not available; SD, standard deviation.

Table 2 Mean (SD) number of missed tablets in 1 year by treatment arm

Data source	Study 1^Citation8	Study 2^Citation10
	Diary card (n=640)	Activated acoustic alarm (n=250)	Deactivated acoustic alarm (n=248)	All patients (n=498)
Based on dispenser data	N/A	1.0 (2.5)a	7.8 (11.7)b	4.4 (9.1)c
Based on diary data	4.3 (4.24)	1.0 (2.4)	2.8 (5.3)	1.9 (4.2)

Notes: Data indicate the values obtained from all women who received at least one dose of study medication and had at least one clinical observation after the administration of study medication. The number of missed pills was normalized to 364 days.

a Dispenser data available for 242 participants.

b Dispenser data available for 246 participants.

c Dispenser data available for 488 participants.

Abbreviations: N/A, not applicable; SD, standard deviation.

KlippingCDuijkersIFortierMPMarrJTrummerDElliesenJContraceptive efficacy and tolerability of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled studyJ Fam Plann Reprod Health Care2012382738322454003

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WiegratzIElliesenJPaolettiAMWalzerAKirschBAdherence 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 studyInt J Womens Health20157192925609999

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