Bleeding Pattern and Management of Unexpected Bleeding/Spotting with an Extended Regimen of a Combination of Ethinylestradiol 20 mcg and Drospirenone 3 mg

Figures & data

Table 1 Summary of Demographic and Baseline Characteristics of Participants Who Were Randomly Assigned (n = 348)

Characteristic	EE/DRSPes (n = 174)	EE/DRSP24/4 (n = 174)	P-value
Age (years)	27.8 (6.1)	27.9 (5.8)	0.921
Marital status – n (%)
Married	54 (31.0)	62 (35.6)
Single	117 (67.2)	107 (61.5)
Divorced/separated	3 (1.7)	5 (2.9)
Age at menarche (years)	12.7 (1.6)	12.4 (1.3)	0.152
Length of menstrual cycle (days)	28.4 (1.4)	28.4 (1.3)	0.693
Duration of period/withdrawal bleeding (days)	4.5 (1.2)	4.5 (1.1)	0.851
OCP users – n (%)	94 (54.0)	88 (50.6)	0.631
Weight (kg)	62.7 (10.6)	64.2 (9.5)	0.146
BMI (kg/m^2)	24.1 (3.5)	24.6 (3.4)	0.183
SBP (mmHg)	111.0 (10.2)	110.7 (9.4)	0.756
DBP (mmHg)	71.0 (8.2)	71.0 (8.1)	0.974

Note: Values presented as the mean (standard deviation) except where indicated.

Abbreviations: OCP, oral contraceptive pill; BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 1 Flow of participants through the trial. EE/DRSP_es = ethinylestradiol 20 mcg + drospirenone 3 mg in an extended regimen. EE/DRSP_24/4 = ethinylestradiol 20 mcg + drospirenone 3 mg in a 24/4 regimen.

Table 2 Median Number of Days During the Entire Treatment Period (ITT, n = 309) Without Bleeding/Spotting, with Bleeding/Spotting, and with Bleeding of Each Intensity Level

Bleeding Pattern	EE/DRSPes	EE/DRSP24/4	P-value
Without bleeding/spotting	144	139	0.007
With bleeding/spotting	17	26	0.004
Spotting	9	10	0.784
Mild bleeding	3	9	< 0.001
Moderate bleeding	0	3	< 0.001
Heavy bleeding	0	0	0.096

Figure 2 Number of days in the total treatment period (ITT, n = 309) with spotting only or bleeding only.

Figure 3 Numbers of days with bleeding or spotting, spotting only, and bleeding only in the 2 90-day reference periods in both groups. (A) Reference Period 1 (RP 1); (B) Reference Period 2 (RP 2).

Figure 4 Percentage of women exhibiting amenorrhea (neither spotting nor bleeding) during each of the 6 28-day treatment intervals. Between-groups difference, P < 0.001.

Figure 5 Percentage of women without bleeding (with or without spotting) during each of the 6 28-day treatment intervals. Between-groups difference, P < 0.001.

Figure 6 Percentage of women in the EE/DRSP_es group who implemented the 4-day HFI for management unexpected bleeding/spotting and the rate of effectiveness thereof during each of the 6 28-day treatment intervals.