|
Baseline |
T1 |
T2 |
p |
p |
VHI Score |
13.4 ± 6.2 |
17.3± 3.4 |
19.5 ±2.7 |
<0.001 |
<0.001 |
VHI Score |
8.5 ± 2.0 |
15.6± 1.7 |
17.9 ±2.9 |
<0.001 |
<0.001 |
Table 1: VHI score for the entire population studied and in the subgroup with baseline VHI <15 diagnosed for atrophic vaginitis
SYMPTOM |
Baseline |
T1 |
T2 |
p T0 vs T1 |
p T0 vs T2 |
Vasomotor symptoms |
44.5% |
40.9% |
12.5% |
NS |
0.001 |
Sleep disorders |
33.3% |
22.7% |
12.5% |
NS |
0.005 |
Mood disturbances |
36.3% |
13.6% |
8.3% |
0.083 |
0.005 |
Table 2: Percentage of patients who reported vasomotor symptoms, sleep disturbances and mood disorders, respectively at T0, T1 and T2.
Hemodynamic and anthropometric measurements |
Baseline |
After 3 mm of treatment T1 |
After 3 mm of treatment T2 |
p T0 vs T1 |
p T0 vs T2 |
Systolic blood pressure (mmHg) |
128.6 ± 15.0 |
120.0 ± 12.6 |
119.95±11.3 |
0.001 |
0.006 |
Diastolic blood pressure (mmHg) |
76.0 ± 9.3 |
70.7 ± 9.1 |
70.2 ± 8.7 |
0.013 |
0.011 |
Heart rate (beats/min) |
77.0 ± 10.1 |
75.1± 9.0 |
76.3 ±8.7 |
NS |
NS |
BMI (kg/m2) |
22.2 ± 3.6 |
22.2 ± 3.1 |
22.4 ± 2.7 |
NS |
NS |
BSA( m2) |
1.62 ± 0.1 |
1.62 ± 0.1 |
1.62 ± 0.1 |
NS |
NS |
Table 3: Changes in hemodynamic and anthropometric measurements after 3 and 12 months of treatment with Ospemifene
PANEL |
PARAMETER |
Baseline (T0) |
3 mm (T1) |
12 mm (T2) |
p |
p |
Metabolism / Liver |
Triglycerides |
71.6±4.5 |
70.4±6.2 |
67.5±5.4 |
NS |
NS |
Metabolism / Liver |
Total Cholesterol |
204.7±6.6 |
196.7±5.3 |
192.6±6.8 |
0.008 |
0.05 |
Metabolism / Liver |
HDL |
78.0±3.1 |
77.6±2.7 |
76.4±2.5 |
NS |
NS |
Metabolism / Liver |
LDL |
110.5±8.3 |
104.2±6.7 |
95.9±13.1 |
0.064 |
NS |
Metabolism / Liver |
gGT |
16.7±2.6 |
16.7±2.0 |
17.7±32.9 |
NS |
NS |
Metabolism / Liver |
AST |
19.9±1.6 |
20.3±2.1 |
20.2±1.2 |
NS |
NS |
Metabolism/ |
ALT |
16.9±1.6 |
15.2±1.1 |
15.8±1.3 |
NS |
NS |
Metabolism / Liver |
Glucose |
89.5±1.5 |
89.0±1.6 |
87.5±1.8 |
NS |
NS |
Metabolism / Liver |
Insulin |
6.8±1.1 |
5.6±01.1 |
5.4±0.3 |
NS |
NS |
Renal function |
Creatinine |
0.69±0.02 |
0.71±0.12 |
0.73±0.03 |
NS |
NS |
Renal function |
Uric acid |
3.8±0.3 |
3.9±0.4 |
3.9±0.4 |
NS |
NS |
Nonspecific indices of inflammation |
Fibrinogen |
325.9±18.1 |
291.7±16.4 |
294.1±11.5 |
0.010 |
0.018 |
Nonspecific indices of inflammation |
PCR |
0.19±0.08 |
0.13±0.02 |
0.11±0.03 |
0.001 |
0.001 |
Nonspecific indices of inflammation |
IL-6 |
1.20±0.22 |
1.30±0.21 |
1.33±0.27 |
NS |
NS |
Nonspecific indices of inflammation |
Vit B12 |
404.8±52.8 |
579.6±156.2 |
444.9±128.5 |
NS |
NS |
Table 4: Concentrations of haematochemical parameters related to various panels: (metabolism / liver; renal function, non-specific indices of inflammation) of the subjects at T0, T1 and T2
PANEL |
PARAMETER |
Baseline (T0) |
3 mm (T1) |
12 mm (T2) |
p |
p |
Coagulation / Thrombotic risk |
ATT_PT |
105.3±2.6 |
106.3±2.8 |
107.0±3.2 |
NS |
NS |
Coagulation / Thrombotic risk |
INR |
0.98±0.01 |
0.98±0.02 |
0.98±0.01 |
NS |
NS |
Coagulation / Thrombotic risk |
aPTT |
30.1±0.6 |
29.0±0.6 |
29.0±0.6 |
NS |
NS |
Coagulation / Thrombotic risk |
AT III |
111.8±4.6 |
107.5±2.6 |
105.1±3.4 |
NS |
NS |
Coagulation / Thrombotic risk |
APC |
3.2±0.4 |
2.9±0.4 |
3.2±0.3 |
NS |
NS |
Coagulation / Thrombotic risk |
Protein C |
117.2.±0.7 |
123.4±5.9 |
124.4±6.9 |
NS |
0.034 |
Coagulation / Thrombotic risk |
Protein S |
85.2±3.4 |
96.3±2.7 |
95.0±3.1 |
0.003 |
0.012 |
Coagulation / Thrombotic risk |
Homocysteine (umol/L) |
9.0±0.6 |
10.1±0.5 |
9.1±0.6 |
NS |
NS |
Coagulation / Thrombotic risk |
nt-proBNP |
53.2±9.1 |
57.4±25.3 |
53.1±10.6 |
NS |
NS |
Table 5: Trend in the concentration of blood chemistry parameters related to coagulation and thrombotic risk at T0, T1 and T2
Tables at a glance
Figures at a glance