Table 3.
Serum hormone concentrations (intent-to-treat population)
| Study visit | Sample timea | Luteinizing hormone | Estradiolb | Testosteroneb | Follicle-stimulating hormone | ||||
|---|---|---|---|---|---|---|---|---|---|
|
Mean ± SE (range) (IU/L) |
N |
Mean ± SE (range) (pg/mL) |
N |
Mean ± SE (range) (ng/dL) |
N |
Mean ± SE (range) (IU/L) |
N | ||
| Screening | Pre-stim | 1.9 ± 0.4 (0.1, 22.0) |
62 | 27.3 ± 3.3 (10.0, 117.1) |
57 | 119.7 ± 40.3 (80.8, 158.6) |
2 | 4.1 ± 0.3 (0.8, 16.9) |
62 |
| Post-stim | 23.5 ± 3.1 (5.1, 112.8) |
62 | 25.6 ± 2.9 (10.0, 120.9) |
59 | 112.5 ± 49.0 (63.5, 161.5) |
2 | 11.0 ± 1.0 (1.1, 52.6) |
62 | |
| Visit 1 (baseline) | Baseline | 3.5 ± 1.2 (0.1, 68.9) |
62 | 25.3 ± 3.3 (10.0, 119.0) |
60 | 285.5 ± 40.4 (245.2, 325.9) |
2 | 3.9 ± 0.3 (0.5, 11.2) |
62 |
| Visit 2 (week 4) | 0.8 ± 0.2 (0.1, 12.2) |
60 | 14.6 ± 3.3 (10.0, 190.1) |
58 | 24.5 ± 13.0 (11.5, 37.5) |
2 | 1.0 ± 0.1 (0.2, 5.5) |
60 | |
| Visit 3 (week 12) | Pre-stim | 0.6 ± 0.1 (0.1, 3.9) |
60 | 10.6 ± 0.3 (10.0, 19.1) |
57 | 15.9 ± 4.3 (11.5, 20.2) |
2 | 1.5 ± 0.1 (0.2, 5.0) |
60 |
| Post-stim | 3.1 ± 0.8 (0.1, 46.7) |
60 | 10.8 ± 0.6 (10.0, 42.8) |
57 | 15.9 ± 4.3 (11.5, 20.2) |
2 | 2.8 ± 0.3 (0.2, 12.5) |
60 | |
| Visit 4 (week 20) | 0.6 ± 0.1 (0.1, 2.1) |
59 | 10.5 ± 0.3 (10.0, 23.2) |
57 | 23.1 ± 11.5 (11.5, 34.6) |
2 | 1.4 ± 0.1 (0.2, 5.1) |
59 | |
| Visit 5 (week 24) | Pre-stim | 0.6 ± 0.1 (0.1, 3.3) |
62 | 10.3 ± 0.2 (10.0, 21.5) |
59 | 18.8 ± 7.2 (11.5, 26.0) |
2 | 1.2 ± 0.1 (0.2, 3.3) |
62 |
| Post-stim | 3.0 ± 0.8 (0.3, 48.1) |
62 | 10.6 ± 0.3 (10.0, 24.5) |
60 | 15.9 ± 4.3 (11.5, 20.2) |
2 | 2.4 ± 0.2 (0.2, 9.2) |
62 | |
| Visit 6 (week 36) | Pre-stim | 0.5 ± 0.1 (0.1, 2.9) |
58 | 10.2 ± 0.2 (10.0, 20.9) |
56 | 11.5 ± 0.0 (11.5, 11.5) |
2 | 1.4 ± 0.1 (0.1, 3.5) |
58 |
| Post-stim | 2.3 ± 0.2 (0.3, 10.1) |
59 | 10.4 ± 0.2 (10.0, 19.9) |
57 | 11.5 ± 0.0 (11.5, 11.5) |
2 | 3.1 ± 0.3 (0.2, 9.6) |
59 | |
| Visit 7 (week 44) | 0.6 ± 0.1 (0.1, 2.5) |
59 | 11.0 ± 0.4 (10.0, 23.4) |
57 | 11.5 ± 0.0 (11.5, 11.5) |
2 | 1.4 ± 0.1 (0.1, 4.0) |
59 | |
| End of treatment (week 48) | Pre-stim | 0.6 ± 0.1 (0.1, 3.3) |
59 | 10.1 ± 0.1 (10.0, 15.5) |
57 | 17.3 ± 5.8 (11.5, 23.1) |
2 | 1.4 ± 0.1 (0.1, 5.4) |
59 |
| Post-stim | 2.3 ± 0.2 (0.3, 8.0) |
58 | 10.5 ± 0.3 (10.0, 22.9) |
56 | 27.4 ± 15.9 (11.5, 43.3) |
2 | 3.0 ± 0.3 (0.1, 13.1) |
58 |
a Pre-stim, prestimulation test; post-stim, poststimulation test.
b No expected change poststimulation at time point measured.