An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch

Figures & data

Table 1 Demographic characteristics of subjects (n=12)

Characteristics	Mean	SD	Range
Age (years)	25	3	20–29
Body weight (kg)	58.4	6.8	48.7–73.5
Height (cm)	161	5	151–169
BMI (kg/m^2)	22.5	2.5	18.8–25.7

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

Table 2 The pharmacokinetic parameters of EE and GSD after a single-dose administration of 30 μg EE/75 μg GSD tablet and 7 days wearing of 1.2 mg EE/1.6 mg GSD study patch (n=12)

Parameters	Tablet (mean ± SD)		Patch (mean ± SD)
	EE	GSD	EE	GSD
Cmax (pg/mL)	74.1±35.6	3,060±1,976	28.8±10.3	1,720±894
tmax (h)	1.5±0.5	0.9±0.4	86±31	144±29
t1/2 (h)	8.4±4.8	9.6±5.8	27.7±34.2	21.1±4.7
CL/F (L/h)	58.0±19.8	7.9±6.6	303.5±100.5	8.5±4.9
Vd/F (L)	625.3±228.7	65.1±26.6	11,745.3±15,934.8	255.4±135.6
AUC0–last (pg·h/mL)	432.0±183.9	14,218±12,290	3,850±1,388	238,119±127,415
AUC0–∞ (pg·h/mL)	487.4±166.6	14,976±11,905	3,895±1,423	242,844±128,196

Abbreviations: C_max, maximum plasma concentration; t_max, time to reach the C_max; t_1/2, elimination half-life; CL/F, apparent plasma clearance; V_d/F, apparent volume of distribution; AUC_0–last, area under the plasma concentration–time curve from 0 to the last time; AUC_0–∞, area under the plasma concentration–time curve from 0 to infinity; EE, ethinylestradiol; GSD, gestodene; SD, standard deviation.

Table 3 The comparisons of main pharmacokinetic parameters of EE and GSD between a single-dose administration of 30 μg EE/75 μg GSD tablet and 7 days wearing of 1.2 mg EE/1.6 mg GSD study patch

Parameters	Patch:tablet ratio (mean value)
	EE	GSD
Cmax	0.4	0.6
tmax	57.3	160.0
t1/2	3.3	2.2
AUC0–∞	8.0	16.2

Abbreviations: C_max, maximum plasma concentration; t_max, time to reach the C_max; t_1/2, elimination half-life; AUC_0–∞, area under the plasma concentration–time curve from 0 to infinity; EE, ethinylestradiol; GSD, gestodene.

Figure 1 The mean plasma concentration versus time profiles of (A) EE and (B) GSD after a single-dose administration of tablet.

Abbreviations: EE, ethinylestradiol; GSD, gestodene.

Figure 2 The mean plasma concentration versus time profiles of (A) EE and (B) GSD after a single-dose administration of the study patch.

Abbreviations: EE, ethinylestradiol; GSD, gestodene.