Table 2 Results of primary, secondary and exploratory endpoints (ITT analyses)
Time | Control | mylovia | ANCOVA | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
n | Mean | SD | n | Mean | SD | Treatment effect (95% CI)a | p | Partial η2 | d (95% CI)b | ||
FSFI | T0 | 123 | 16.9 | 6.0 | 129 | 15.6 | 5.9 | – | – | – | – |
T1 | 123 | 17.3 | 8.1 | 129 | 20.3 | 7.4 | 3.7 (1.7, 5.6) | <0.001 | 0.06 | 0.51 (0.23, 0.79) | |
T2 | 123 | 18.5 | 8.6 | 129 | 19.9 | 8.1 | 2.0 (0, 4.0) | 0.048 | 0.02 | 0.26 (0, 0.52) | |
PHQ-9 | T0 | 123 | 6.3 | 4.1 | 129 | 6.6 | 3.9 | – | – | – | – |
T1 | 123 | 6.7 | 4.0 | 129 | 6.7 | 4.1 | −0.1 (−0.9, 0.7) | 0.730 | 0 | 0.04 (−0.21, 0.30) | |
T2 | 123 | 6.8 | 4.1 | 129 | 6.1 | 3.5 | −0.8 (−1.6, 0) | 0.063 | 0.02 | 0.25 (−0.01, 0.50) | |
SIDI-F-SR | T0 | 123 | 20.2 | 9.6 | 129 | 18.4 | 9.1 | – | – | – | – |
T1 | 123 | 20.5 | 10.9 | 129 | 23.0 | 10.2 | 3.1 (0.5, 5.6) | 0.020 | 0.03 | 0.30 (0.04, 0.56) | |
T2 | 123 | 22.0 | 12.1 | 129 | 23.8 | 9.9 | 2.2 (−0.6, 5.1) | 0.128 | 0.02 | 0.21 (−0.06, 0.48) | |
NSSS-SF | T0 | 123 | 30.9 | 8.5 | 129 | 27.6 | 7.5 | – | – | – | – |
T1 | 123 | 32.1 | 9.4 | 129 | 33.2 | 8.7 | 2.6 (0.4, 4.8) | 0.020 | 0.03 | 0.31 (0.05, 0.58) | |
T2 | 123 | 33.7 | 10.1 | 129 | 33.6 | 10.1 | 1.6 (−0.9, 4.1) | 0.206 | 0.01 | 0.18 (−0.10, 0.45) | |
Sexual Pain | T0 | 123 | 34.5 | 24.1 | 129 | 33.0 | 22.7 | – | – | – | – |
T1 | 123 | 32.1 | 22.1 | 129 | 24.9 | 18.5 | −6.2 (−9.6, −2.9) | <0.001 | 0.06 | 0.49 (0.21, 0.76) | |
T2 | 123 | 31.2 | 23.6 | 129 | 24.3 | 18.2 | −5.8 (−9.5, −2) | 0.003 | 0.04 | 0.40 (0.14, 0.65) | |
