Efficacy and safety of ultra-low-dose estradiol and norethisterone in postmenopausal Brazilian women

Figures & data

Figure 1. Flow chart of participants included in the study. E2, 17β-estradiol; ITT, intention-to-treat; NETA, norethisterone acetate; PP, per protocol.

Table 1. Demographic and clinical baseline characteristics of participants according to treatment group.

Variable	E2 0.5 mg 17β-E2 /0.1 mg NETA (n = 58)	Placebo (n = 60)	All (n = 118)	p-Value
Age (years)
Mean (±SD)	53.4 (4.0)	54.1 (3.7)	53.8 (3.9)	0.27^a
Range	45–60	45–60	45–60
Race, n (%)
White	45 (77.6)	45 (75.0)	90 (76.3)
Black	6 (10.3)	9 (15.0)	15 (12.7)	0.900^b
Asian	1 (1.7)	1 (1.7)	2 (1.7)
Other	6 (10.3)	5 (8.3)	11 (9.3)
Bodyweight (kg)
Mean (±SD)	69.0 (11.4)	68.9 (9.7)	68.9 (10.5)	0.830^a
Range	48.7–98.0	50.0–98.0	48.7–98.0
Body mass index (kg/m^2)
Mean (±SD)	27.2 (3.8)	27.6 (3.5)	27.4 (3.7)	0.620^a
Range	20.5–35.1	21.4–34.8	20.5–35.1
Systolic blood pressure (mmHg)
Mean (±SD)	120.1 (10.3)	119.4 (11.4)	119.7 (10.9)
Range	100–150	90–150	90–150	0.670^a
Diastolic blood pressure (mmHg)
Mean (±SD)	75.8 (7.0)	76.9 (8.1)	76.4 (7.6)	0.484^a
Range	60–90	50–90	50–90
Estradiol (pg/ml)
Mean (±SD)	17.3 (6.7)	15.1 (5.1)	16.2 (6.0)	0.050^a
FSH (mUI/ml)
Mean (±SD)	89.9 (32.5)	85.0 (26.6)	87.5 (29.6)	0.462^a
Smokers, n (%)	11 (19.0)	12 (20.0)	23 (19.5)	0.887^b

^aStudent’s t-test.

^bChi-square test.

17β-E2, 17β-estradiol; FSH, follicle stimulating hormone; NETA, norethisterone acetate; SD, standard deviation.

Figure 2. Number of hot flushes per week before and at the end of treatment (intention-to-treat [ITT] analysis population). 17β-E2, 17β-estradiol; NETA, norethisterone acetate.

Figure 3. Mean number of hot flushes by week in both groups (0.5 mg 17β-estradiol [17β-E2]/0.1 mg norethisterone acetate [NETA] and placebo group). Intention-to-treat (ITT) analysis population.

Figure 4. Percentage change of hot flush weekly weighted score (HFWWS) at weeks 4, 8, 12 and 24 of treatment compared to baseline. Intention-to-treat (ITT) analysis population. HFWWS = (mild hot flushes × 1) + (moderate hot flushes × 2) + (severe hot flushes × 3). 17β-E2, 17β-estradiol; NETA, norethisterone acetate.

Table 2. Severity score of vasomotor symptoms before and at end of treatment (intention-to-treat [ITT] analysis population): hot flush weekly weighted score.

Severity score of vasomotor symptoms	0.5 mg 17β-E2 / 0.1 mg NETA
Baseline (mean of 2 weeks)
Mean (SD)	192 (60.8)
Median	181
Minimum–maximum	97.5–336
n	52
Cycle 1 (week 4)
Mean (SD)	87.4 (62.1)
Median	84
Minimum–maximum	0–242
n	49
Cycle 2 (week 8)
Mean (SD)	58.0 (67.0)
Median	42.0
Minimum–maximum	0–336
n	47
Cycle 3 (week 12)
Mean (SD)	49.9 (68.4)
Median	25.0
Minimum–maximum	0–336
n	49
Cycle 6 (week 24)
Mean (SD)	33.1 (70.4)
Median	9.0
Minimum–maximum	0–336
n	49
p-Value^a
Treatment × cycle interaction	0.369
Treatment	<0.0001
Cycle	<0.0001

^aMixed model with repeated measures.

17β-E2, 17β-estradiol; NETA, norethisterone acetate; SD, standard deviation.