Table 2.
Median reproductive hormone values (interquartile range) in cycles 1 and 2
| Reproductive hormone | Placebo (n = 8) | Elinzanetant 40 mg (n = 7) | |||||
|---|---|---|---|---|---|---|---|
| C1 | C2 | Change | C1 | C2 | Change | ||
| LH, IU/L | Day 3 or 4 | 1.90 (2.15) | 2.20 (1.63) | 0.80 | 1.80 (1.20) | 1.40 (1.00) | 0.00 |
| Day 9 or 10 | 2.60 (1.38) | 2.10 (0.45) | –0.45 | 2.40 (3.10) | 2.90 (8.00) | 0.60 | |
| Day 15 or 16 | 3.40 (2.15) | 4.00 (4.45) | 0.95 | 2.50 (4.30) | 1.60 (7.60) | –0.80 | |
| Day 21 or 22 | 1.90 (2.48) | 1.35 (1.45) | –0.50 | 2.30 (2.10) | 0.80 (1.10) | –0.50 | |
| FSH, IU/L | Day 3 or 4 | 2.35 (1.50) | 2.85 (1.45) | 0.75 | 2.80 (1.00) | 2.30 (0.60) | –0.80 |
| Day 9 or 10 | 2.15 (1.20) | 1.95 (0.75) | 0.05 | 2.90 (1.40) | 2.60 (1.30) | 0.10 | |
| Day 15 or 16 | 2.70 (0.68) | 2.80 (2.10) | 0.30 | 1.70 (2.00) | 1.90 (4.40) | –0.20 | |
| Day 21 or 22 | 1.70 (0.60) | 1.60 (0.88) | –0.10 | 2.00 (1.50) | 1.60 (0.80) | –0.50 | |
| Estradiol, pmol/L | Day 3 or 4 | 101.0 (263.0) | 138.0 (95.5) | 24.0 | 136.0 (81.0) | 117.0 (139.0) | 4.0 |
| Day 9 or 10 | 273.5 (186.3) | 279.0 (187) | –0.5 | 334.0 (469) | 418.0 (792.0) | –47.0 | |
| Day 15 or 16 | 271.5 (437.7) | 273.5 (437.5) | –18.0 | 558.0 (401.0) | 290.0 (330.0) | –224.0 | |
| Day 21 or 22 | 284.5 (221.0) | 422.5 (116.5) | 40.5 | 444.0 (287.0) | 433.0 (404) | –63.0 | |
| Progesterone, nmol/L | Day 3 or 4 | 1.745 (14.710) | 1.270 (10.020) | 0.000 | 0.640 (0.320) | 0.320 (0.630) | 0.000 |
| Day 9 or 10 | 0.320 (0.320) | 0.320 (0.240) | 0.000 | 0.320 (0.000) | 0.320 (0.000) | 0.000 | |
| Day 15 or 16 | 3.815 (8.985) | 3.335 (13.280) | –2.065 | 4.770 (32.430) | 17.490 (41.340) | 0.000 | |
| Day 21 or 22 | 39.590 (22.890) | 45.315 (15.420) | 3.180 | 23.530 (17.81) | 28.940 (48.330) | 7.950 | |
| Reproductive hormone | Elinzanetant 80 mg (N = 8) | Elinzanetant 120 mg (N = 8) | |||||
| C1 | C2 | Change | C1 | C2 | Change | ||
| LH, IU/L | Day 3 or 4 | 1.60 (1.48) | 2.35 (2.43) | 0.70 | 1.45 (1.65) | 1.20 (1.30) | –0.90 |
| Day 9 or 10 | 1.80 (3.25) | 2.60 (4.60) | 0.15 | 3.20 (2.48) | 1.35 (0.55) | –0.70 | |
| Day 15 or 16 | 5.60 (22.98) | 4.10 (6.33) | –2.40 | 2.45 (3.28) | 2.35 (2.60) | 0.60 | |
| Day 21 or 22 | 1.75 (0.80) | 3.20 (3.35) | 1.25 | 1.25 (1.70) | 2.10 (1.30) | 0.35 | |
| FSH, IU/L | Day 3 or 4 | 2.70 (2.40) | 3.35 (1.65) | 0.45 | 3.25 (3.05) | 2.25 (0.90) | –1.15 |
| Day 9 or 10 | 3.95 (2.65) | 3.65 (3.23) | –0.30 | 2.35 (2.80) | 3.40 (1.60) | 1.00 | |
| Day 15 or 16 | 3.75 (6.45) | 3.35 (2.33) | –0.55 | 2.15 (2.00) | 2.90 (1.80) | 1.05 | |
| Day 21 or 22 | 2.15 (1.60) | 2.50 (2.50) | 0.30 | 1.45 (1.05) | 2.25 (1.18) | 0.50 | |
| Estradiol, pmol/L | Day 3 or 4 | 147.0 (78.8) | 97.5 (69.3) | –20.0 | 154.5 (131.5) | 80.5 (56.5) | –66.0 |
| Day 9 or 10 | 215.0 (297.2) | 165.0 (136.0) | –38.5 | 315.5 (214.8) | 102.5 (105.8) | –193.0 | |
| Day 15 or 16 | 562.0 (517.0) | 295.5 (349.2) | –187.5 | 222.0 (147.0) | 110.0 (222.3) | –112.0 | |
| Day 21 or 22 | 406.0 (292.3) | 247.5 (276.5) | –112.0 | 510.0 (414.5) | 327.0 (291.7) | –178.0 | |
| Progesterone, nmol/L | Day 3 or 4 | 0.795 (3.653) | 0.640 (0.950) | 0.000 | 0.320 (0.240) | 0.320 (0.240) | 0.000 |
| Day 9 or 10 | 0.320 (0.000) | 0.320 (0.000) | 0.000 | 0.320 (0.000) | 0.320 (0.000) | 0.000 | |
| Day 15 or 16 | 1.430 (13.910) | 0.635 (7.075) | 0.000 | 4.390 (12.163) | 0.320 (0.713) | –2.860 | |
| Day 21 or 22 | 31.800 (18.690) | 18.125 (25.120) | –5.720 | 45.630 (44.997) | 0.320 (24.25) | –19.400 | |
The median of change from baseline (cycle 1) for each time point was calculated based on the Hodges-Lehmann estimate.
Abbreviations: C1, cycle 1; C2, cycle 2; FSH, follicle-stimulating hormone; IQR, interquartile range; LH, luteinizing hormone.