Table 3.
Summary of main pharmacodynamic outcomes
| Placebo | Silexan | |
|---|---|---|
| Hoogland score (n = 22) | ||
| No activitya | 20 (90.9 %) | 16 (72.7 %) |
| Potential activityb | 1 (4.5 %) | 6 (27.3 %) |
| Active follicle-like structurec | 1 (4.5 %) | 0 (0.0 %) |
| Follicle size, right (mm) (n = 22) | ||
| Day 7 | 7.1 ± 4.1 | 6.6 ± 2.0 |
| Day 14 | 6.1 ± 3.6 | 5.0 ± 1.0 |
| Day 21 | 5.1 ± 1.3 | 4.8 ± 0.8 |
| Day 28 | 6.9 ± 1.5 | 7.3 ± 1.7 |
| Follicle size, left (mm) (n = 22) | ||
| Day 7 | 6.4 ± 1.7 | 6.4 ± 2.1 |
| Day 14 | 5.3 ± 1.0 | 5.0 ± 0.8 |
| Day 21 | 4.9 ± 0.9 | 5.0 ± 0.8 |
| Day 28 | 7.0 ± 1.9 | 6.7 ± 1.7 |
| Endometrial thickness (mm) (n = 22) | ||
| Day 7 | 4.1 ± 1.1 | 4.4 ± 1.0 |
| Day 14 | 4.0 ± 1.1 | 4.5 ± 1.5 |
| Day 21 | 4.5 ± 1.8 | 4.1 ± 1.1 |
| Day 28 | 3.6 ± 1.1 | 3.8 ± 1.2 |
| Progesterone (nmol/l) (n = 24) | ||
| Day 7 | 1.2 ± 0.6 | 1.2 ± 0.6 |
| Day 14 | 1.2 ± 0.6 | 1.1 ± 0.5 |
| Day 21 | 1.1 ± 0.7 | 1.2 ± 0.6 |
| Day 28 | 1.3 ± 0.7 | 1.3 ± 0.7 |
| Estradiol (pg/ml) (n = 24) | ||
| Day 7 | 32.9 ± 114.6 | 31.2 ± 107.7 |
| Day 14 | 8.1 ± 7.2 | 10.9 ± 6.6 |
| Day 21 | 7.3 ± 6.0 | 7.5 ± 5.6 |
| Day 28 | 44.9 ± 37.8 | 42.4 ± 32.0 |
| SHBG (nmol/l) (n = 24) | ||
| Day 21 | 112.7 ± 40.0 | 113.5 ± 40.9 |
Data are presented as mean ± SD or number (%)
aFollicle size ≤10.0 mm
bFollicle size 10.1–13.0 mm
cFollicle size >13.0 mm, progesterone ≤5 nmol/l, estradiol >30 pg/ml
SD standard deviation, SHBG sex hormone-binding globulin