Table 6.
Phase 3 study PK results comparing AR HG patients to overall ITT study population
| AR patients | Non-AR patients | p | |
|---|---|---|---|
| n, completed | 52 | 223 | |
| Baseline characteristics | |||
| Mean age, y | 55.2 | 54.4 | 0.649 |
| Mean weight, kg | 93.8 | 91.2 | 0.756 |
| Mean BMI | 29.8 | 29.7 | 0.820 |
| Hypogonadism mean duration, y | 5.7 | 4.5 | 0.135 |
| Etiology, secondary hypogonadism | 86.5% | 83.9% | — |
| Mean total testosterone, nd/dL | 250 | 229 | 0.098 |
| Mean estradiol at screening | 22.0 | 19.5 | 0.030 |
| Mean DHT at screening | 21.8 | 18.5 | 0.052 |
| Mean FSH | 6.31 | 8.66 | 0.062 |
| Mean LH | 4.36 | 5.81 | 0.023 |
| Mean SHBG | 27.5 | 29.5 | 0.247 |
| Testosterone levels after 90 days treatment | |||
| Mean Cmax, ng/dL | 1009 | 978.3 | 0.604 |
| Mean AUC 0–24h, ng h/dL | 8598 | 9283 | 0.054 |
| Mean Cavg, ng/dL | 358 | 387 | 0.054 |
| Mean Cavg 22 mg dose, ng/dL | 361 (88.4) | 378 (136) | 0.955 |
| Mean Cavg 33 mg dose, ng/dL | 353 (89.5) | 394 (115) | 0.092 |
| n in the normal range (%) | 71.4% | 73.7% | — |
| Mean Cavg estradiol | 25.8 | 25.0 | 0.534 |
| Mean Cavg DHT | 31.9 | 35.7 | 0.077 |
| Mean FSH | 3.75 | 5.29 | 0.233 |
| Mean LH | 2.30 | 3.06 | 0.206 |
| Mean SHBG | 23.0 | 24.4 | 0.342 |
AR: allergic rhinitis; BMI: body mass index; Cavg: average of the observed concentration; Cmax: maximum observed concentration; Cmin: minimum observed concentration; DHT: dihydrotestosterone; FSH: follicle-stimulating hormone; ITT: intention to treat; LH: luteinizing hormone; SHBG: sex hormone-binding globulin.