Table 2.
Median (IQR)b | 24-Hour periodc | Morning windowd | ||||
---|---|---|---|---|---|---|
At baseline (BL) | At day 14 (D14) | Change from BL to D14 | At baseline (BL) | At day 14 (D14) | Change from BL to D14 | |
ACTH, pg/mL | 59 (113) | 34 (18) | −28 (79) | 226 (377) | 74 (100) | −127 (224) |
17OHP, ng/dL | 2740 (3850) | 668 (1277) | −1965 (3543) | 7704 (7123) | 1789 (3847) | −6265 (7425) |
Androstenedione, ng/dL | 216 (277) | 80 (98) | −105 (273) | 368 (393) | 134 (184) | −236 (391) |
Testosterone (females), ng/dL | 26 (116) | 25 (18) | −16 (109) | 64 (270) | 40 (40) | −53 (247) |
Testosterone (males), ng/dL | 187 (67) | 245 (63) | 28 (33) | 222 (140) | 332 (128) | 3 (120) |
Androstenedione/testosterone ratio (males) | 1.6 (1.9) | 0.2 (1.6) | −0.4 (2.5) | 1.9 (1.3) | 0.3 (1.9) | −0.6 (2.3) |
Abbreviations: 17OHP, 17-hydroxyprogesterone; ACTH, adrenocorticotropic hormone; IQR, interquartile range (Q3-Q1); SI, International System of Units.
Upper limits of normal for adolescents aged 13-17 are as follows: ACTH, 55 pg/mL; 17OHP (females), 208 ng/dL; 17OHP (males), 140-192 ng/dL; androstenedione (females), 200-212 ng/dL; androstenedione (males), 94-113 ng/dL; total testosterone (females), 76 ng/dL; total testosterone (males), 800-827 ng/dL. For SI calculation, conversion factors are as follows: ACTH (pg/mL to pmol/L), 0.22; 17OHP (ng/dL to nmol/L), 0.0303; androstenedione (ng/dL to nmol/L), 0.0349; testosterone (ng/dL to nmol/L), 0.0347.
The number of participants included for analyses were as follows: ACTH, 17OHP, and androstenedione, n = 8; testosterone (females), n = 5; testosterone (males) and androstenedione/testosterone ratio (males), n = 3.
Based on each participant's average values from all timepoints in the serial blood sampling period (from 18:45 [pre-dose] to 19:00 the following day).
Based on each participant's average values from the morning window timepoints (07:00, 10:00).