
Table 1: Clinical characteristics of the enrolled participants (FAS)
Characteristics |
Test group A (n=38) |
Control group B (n=37) |
Statistics (p-value) |
Age (years): |
52.1±5.2 |
50.9±6.3 |
0.337a |
Menopause |
24 (63.2%) |
23 (60.5%) |
0.813b |
Contraception |
|
|
0.700b |
IUD |
3 (7.9%) |
6 (16.2%) |
|
Condom |
1 (2.6%) |
1 (2.7%) |
|
Other |
10 (26.3%) |
8 (21.6%) |
aStudent’s T-test; 2Chi-square test;
Table 2: The primary efficacy endpoint for the improvement of vaginal dryness (FAS)
Characteristics |
Visit |
Groups |
Median (minimum, maximum) |
IQR |
Statistics (p-value) |
Vaginal dryness score |
1st visit |
Treatment group |
8.0(4,12) |
5.3 |
0.741 |
Control group |
8.0(4,13) |
5.0 |
|||
Final visit |
Treatment group |
10.0(7,15) |
3.0 |
0.225 |
|
Control group |
9.5(6,15) |
4.0 |
|||
Score changes |
|
Treatment group |
3.0(-1,5) |
1.0 |
0.005 |
Control group |
2.0 |
||||
Score change ratio (%) |
|
Treatment group |
33.3(-11.1,125) |
25.0 |
0.050 |
Control group |
28.5 |
||||
Improved of vaginal dryness (%) |
|
Treatment group |
24 (63.2) |
0.039 |
|
Control group |
15(39.5) |
IQR: Interquartile Range.
Visit |
Groups |
Frequency count for each point scale |
Statistics (p-value) |
|||||
1 |
2 |
3 |
4 |
5 |
||||
Vaginal elasticity |
1st visit |
Treatment group |
0 |
18 |
10 |
10 |
0 |
0.292 |
Control group |
0 |
14 |
15 |
7 |
2 |
|||
Final visit |
Treatment group |
0 |
1 |
22 |
7 |
8 |
0.013 |
|
Control group |
0 |
8 |
13 |
13 |
4 |
|||
Vaginal moisture |
1st visit |
Treatment group |
2 |
13 |
12 |
11 |
0 |
0.967 |
Control group |
3 |
11 |
14 |
9 |
1 |
|||
Final visit |
Treatment group |
0 |
2 |
16 |
13 |
7 |
0.423 |
|
Control group |
0 |
5 |
19 |
8 |
6 |
|||
Vaginal secretions |
1st visit |
Treatment group |
8 |
14 |
7 |
9 |
0 |
0.968 |
Control group |
8 |
12 |
9 |
9 |
|
|||
Final visit |
Treatment group |
1 |
3 |
17 |
11 |
6 |
0.507 |
|
Control group |
0 |
8 |
16 |
9 |
5 |
Table 4: Change of vaginal pH between treatment of control groups (PPS)
Characteristic |
Visit |
Groups |
Median |
Quartile |
Range |
Statistics (p-value) |
Vaginal pH |
1st visit |
Treatment group |
5.1 |
0.8 |
4.1~5.4 |
0.103 |
Control group |
4.8 |
0.7 |
4.1~5.4 |
|||
Final visit |
Treatment group |
4.8 |
0.7 |
3.8~5.4 |
0.357 |
|
Control group |
4.8 |
0.6 |
4.1~5.4 |
Table 5: Improvement of vulvar and vaginal sting, and dyspareunia (FAS)
Characteristic |
Visit |
Groups |
Frequency count for each point scale |
Statistics(P) |
|||
1 |
2 |
3 |
4 |
||||
1st visit |
Treatment group |
4 |
19 |
13 |
2 |
>0.999 |
|
Control group |
3 |
20 |
13 |
2 |
|||
Final visit |
Treatment group |
1 |
4 |
20 |
13 |
0.882 |
|
Control group |
1 |
6 |
20 |
11 |
|||
Dyspareunia |
1st visit |
Treatment group |
6 |
13 |
18 |
1 |
0.710 |
Control group |
4 |
15 |
16 |
3 |
|||
Final visit |
Treatment group |
0 |
7 |
22 |
6 |
0.648 |
|
Control group |
1 |
4 |
22 |
8 |
Table 6: Symptomatic relief time (FAS)
Relief time (days) |
||||||
Groups |
1-2days |
3-4days |
5-6days |
>7days |
None |
Statistics(p-value) |
Treatment group A |
0 |
5 |
13 |
20 |
0 |
0.329 |
Control group B |
1 |
3 |
10 |
21 |
2 |
Table 7: Satisfaction evaluation at the final visit (FAS)
Groups |
Very satisfied |
Satisfied |
Less satisfied |
Dissatisfied |
Not rated |
Statistics(p-value) |
Treatment group A |
7 |
17 |
14 |
0 |
0 |
0.001 |
Control group B |
1 |
8 |
21 |
6 |
2 |
Tables at a glance
Figures at a glance