Table 2.
Vasomotor symptom (VMS) Outcomes reported as VMS Score#, frequency (actual number/24-h day) and Intensity (on a 1–4 scale on which ≥ 2 involves sweating), PHQ-9 and Perimenopause Interference Questionnaire in intent to treat analysis in Perimenopausal Women Randomized to Oral Micronized Progesterone or Placebo. Data are reported as mean and standard deviation (SD). Risk ratio (RR) and risk difference (RD) are also presented.
| Variables | All (n = 189) | Progesterone (n = 93) | Control (n = 96) | RR (95%CI)* RD (95%CI)* |
*P |
|---|---|---|---|---|---|
| VMS Score –baseline | 12.2 (11.3) | 12.1 (10.5) | 12.3 (12.2) |
0.96 (0.77, 1.18) − 0.54 (− 3.11, 2.03) |
0.680 |
| VMS Score – 1st month | 9.0 (11.0) | 8.6 (9.5) | 9.4 (12.3) |
1.02 (0.77, 1.35) 0.15 (− 2.33, 2.64) |
0.903 |
| VMS Score – 2nd month | 6.6 (9.4) | 5.3 (7.0) | 8.0 (11.2) |
0.74 (0.53, 1.01) − 1.96 (− 4.03, 0.12) |
0.060 |
| VMS Score – 3rd month | 6.2 (9.3) | 5.5 (8.2) | 7.1 (10.4) |
0.79 (0.54, 1.15) − 1.51 (− 3.97, 0.95) |
0.222 |
|
VMS frequency – baseline month per 24-h day |
4.9 (3.8) | 4.9 (3.6) | 4.9 (4.0) |
0.97 (0.81, 1.17) − 0.12 (− 1.01, 0.76) |
0.783 |
|
VMS frequency –1st month per 24-h day |
3.7 (3.7) | 3.5 (3.2) | 3.9 (4.2) |
0.99 (0.79, 1.25) − 0.03 (− 0.86, 0.80) |
0.951 |
|
VMS frequency – 2nd month per 24-h day |
2.9 (3.2) | 2.5 (2.6) | 3.2 (3.7) |
0.81 (0.61, 1.06) − 0.60 (− 1.35, 0.16) |
0.116 |
|
VMS frequency – 3rd month per 24-h day |
2.7 (3.2) | 2.4 (2.7) | 3.0 (3.7) |
0.80 (0.58, 1.11) − 0.60 (− 1.50, 0.29) |
0.179 |
| VMS intensity – baseline | 2.3 (0.7) | 2.3 (0.7) | 2.3 (0.7) |
0.98 (0.90, 1.07) − 0.04 (− 0.24, 0.15) |
0.671 |
| VMS intensity – 1st month | 1.8 (1.0) | 1.8 (1.0) | 1.8 (0.9) |
1.06 (0.89, 1.26) 0.10 (− 0.22, 0.42) |
0.539 |
| VMS intensity –2nd month | 1.6 (1.0) | 1.4 (1.0) | 1.7 (1.0) |
0.85 (0.68, 1.06) − 0.26 (− 0.60, 0.08) |
0.138 |
| VMS intensity – 3rd month | 1.4 (1.0) | 1.4 (1.0) | 1.5 (1.0) |
0.89 (0.69, 1.15) − 0.17 (− 0.56, 0.22) |
0.386 |
| Perimenopause Interference Questionnaire | 25.3 (20.2) | 22.6 (18.3) | 28.2 (21.7) | − 6.65 (− 12.11, − 1.18)^ | 0.017 |
| Personal Health Questionnaire 9 (PHQ-9) | 5.1 (4.4) | 4.8 (4.4) | 5.4 (4.3) |
− 0.40 (− 1.57, 0.77)^ |
0.501 |
#VMS Score is the daytime number X intensity plus the nighttime number X intensity.
*Based on negative binomial regression adjusted for perimenopause phase (EP/LP) and log of the average daily run-in VMS Score (when applicable). Please refer to Statistical Considerations.
^Based on linear regression adjusted for perimenopausal phase status (EP/LP). Results presented as mean difference. Bolded P values are statistically significant