Table 2.
Laboratory parameters at baseline and after 24 wk of treatment with 40 mg estetrol or placebo daily coadministration in patients with prostate cancer treated with an LHRH agonist (per-protocol population)
| Laboratory parameter | 40 mg Estetrol |
Placebo |
|||||
|---|---|---|---|---|---|---|---|
| (N = 37) |
(N = 20) |
||||||
| Baseline | End of treatment (week 24) | Percentage change from baseline | Baseline | End of treatment (week 24) | Percentage change from baseline | p valuea | |
| PSA (ng/ml) | 18.4 (22.10) | 0.6 (2.12) | –96.4 (5.3) | 33.5 (56.98) | 4.0 (9.54) | –83.1 (30.2) | 0.0033 |
| Testosterone, total (nmol/l) | 19.4 (8.54) | 0.5 (0.22) | –97.1 (1.6) | 19.1 (6.55) | 0.5 (0.21) | –97.4 (1.5) | 0.2819 |
| Testosterone, free (pmol/l) | 42.0 (17.36) | 2.4 (0.97) | –93.2 (4.0) | 37.7 (15.62) | 3.2 (1.57) | –89.7 (6.9) | 0.0389 |
| LH level (IU/l) | 10.2 (9.34) | 0.2 (0.17) | –97.6 (1.8) | 11.9 (11.49) | 0.17 (0.09) | –97.6 (2.8) | 0.6805 |
| FSH level (IU/l) | 11.3 (11.29) | 0.2 (0.09) | –97.8 (1.7) | 12.7 (9.48) | 5.5 (3.20) | –56.7 (44.8) | <0.0001 |
| Estradiol (pmol/l) | 98.5 (39.72) | 17.4 (12.40) | –81.6 (10.5) | 113.4 (47.71) | 17.1 (13.46) | –82.3 (14.9) | 0.7639 |
| SHBG (nmol/l) | 61.3 (26.80) | 166.6 (78.13) | +185.0 (111.4) | 69.1 (29.89) | 66.4 (28.25) | –2.5 (15.8) | <0.0001 |
| DHEA-S (µmol/l) | 3.5 (2.05) | 2.5 (1.35) | –26.8 (18.9) | 3.8 (1.97) | 2.8 (1.70) | –26.8 (18.8) | 0.5875 |
| Osteocalcin (ng/ml) | 18.2 (7.29) | 14.0 (6.63) | –22.0 (19.7) | 17.6 (5.19) | 25.0 (8.28) | +47.6 (47.2) | <0.0001 |
| CTX1 (ng/ml) | 309.5 (168.1) | 219.9 (117.9) | –24.8 (34.6) | 300.3 (124.7) | 678.6 (267.0) | +151.1 (109.1) | <0.0001 |
CTX1 = type I collagen telopeptide; DHEA-S = dehydroepiandrosterone-sulfate; FSH = follicle-stimulating hormone; PSA = prostate-specific antigen; LH = luteinizing hormone, LHRH = luteinizing hormone-releasing hormone; SHBG = sex hormone–binding globulin.
Results reported as mean (standard deviation).
a
Kruskall-Wallis test comparing week 24 laboratory levels of 40 mg estetrol with placebo (p values are printed in bold if statistically significant).