Testosterone supplementation for hypogonadal men by the nasal route

Figures & data

Table I.  Subjects' baseline characteristics in study B.

All subjects (n = 21) mean ± SD	Age (years)	Weight (kg)	Height (cm)	BMI (kg/m^2)	Total T (ng/dL)	DHT (ng/dL)
Group B1 (n = 7)	32.0 ± 11.8	68.7 ± 18.1	168.0 ± 16.9	23.8 ± 2.7	29.9 ± 29.8	5.9 ± 4.0
Group B2 (n = 7)	34.0 ± 8.3	80.9 ± 24.7	166.3 ± 16.4	28.3 ± 5.3	35.9 ± 59.6	8.4 ± 4.8
Group B3 (n = 7)	31.4 ± 9.9	68.7 ± 16.8	163.9 ± 12.3	25.3 ± 4.2	13.1 ± 14.6	4.4 ± 0.5

Diagnosis: primary hypogonadism (n = 2): hypergonadotropic hypogonadism NOS (1), Klinefelter syndrome (1).

Secondary hypogonadism (n = 19): panhypopituitarism NOS (14); panhypopituitarism, post-traumatic (1); panhypopituitarism, post-operative (3); Kallmann's syndrome (1).

Figure 1. Pharmacokinetic profile of TT (solid squares) and DHT (open squares) after single-dose administration of different doses of MPP 10 in study A. 7.6 mg T (squares), 15.2 mg T (circles), 22.8 mg T (triangles). Dashed line denotes lower limits of normal range of TT based on morning serum samples. Error bars denote mean ± SD.

Table II.  Pharmacokinetic parameters of TT in study A after single escalating doses of MPP 10 in 8 men.

Parameter	7.6 mg	15.2 mg	22.8 mg
Cmax*[ng/dL]	578 ± 234	804 ± 315	842 ± 431
tmax[h]	1.08 ± 0.71	1.40 ± 0.94	1.02 ± 0.68
AUC0–24 h*[ng*h/dL]	2315 ± 1380	4222 ± 1849	4366 ± 2198
NAUC0–24 h**[ng*h/dL]/mg	305 ± 182	278 ± 122	191 ± 96

Values given as mean ± SD.

*Baseline-corrected values.

**Normalised baseline-corrected AUC.

Figure 2. Pharmacokinetic profile of TT and DHT after nasal administration of MPP 10 in different dosing schemes (Study B, after 14 days of treatment). ‘Time 0’ means 08:00 h; dashed lines denote upper (TT and DHT) and lower (TT) limits of normal range based on morning serum samples. Error bars denote mean ± SD.

Table III.  Study B.

Parameter	Group B1	Group B2	Group B3
Cav[ng/dL]	314 (236–419)	327 (210–509)	472 (323–689)
Cmin[ng/dL]	102 (55–189)	157 (98–251)	220 (116–419)
Cmax[ng/dL]	859 (632–1,167)	854 (465–1,570)	1,137 (895–1,444)
PTF	2.50 ± 1.06	2.22 ± 0.71	2.02 ± 0.93
AUC0–24 h*[ng*h/dL]	6,879 ± 2,679	7,764 ± 4,795	12,031 ± 4,591
NAUC0–24 h**[ng*h/dL]/mg	453 ± 176	511 ± 315	528 ± 201

Pharmacokinetic data of testosterone after repeat administration of different daily doses of MPP 10 (mean ± SD or geometric mean and 95% CI).

*Baseline-corrected values.

**Normalised baseline-corrected AUC.

Table IV.  Study B.

Parameter	Group B1	Group B2	Group B3
Cav[ng/dL]	26.2 (18.4–37.5)	26.3 (13.5–51.5)	34.7 (20.5–58.7)
Cmin[ng/dL]	13.5 (8.2–22.1)	15.6 (8.2–29.7)	16.8 (8.9–31.9)
Cmax[ng/dL]	43.5 (31.8–59.6)	46.4 (21.3–101)	70.0 (40.1–122)
PTF	1.15 ± 0.43	1.19 ± 0.32	1.68 ± 1.09
AUC0-24 h [ng*h/dL]	577 (415–803)	632 (339–1,177)	833 (512)

Pharmacokinetic data of DHT after repeat administration of different daily doses of MPP 10 (mean ± SD or geometric mean and 95% CI).

Figure 3. Overall CGS for study B.

Figure 4. Pharmacokinetic profile of TT in group B₂ on last day of treatment (study B, day 14) in comparison with profile of a healthy young man (data taken from Diver [37]; ‘time 0’ means 08:00 h). Dashed lines denote upper and lower limits of normal range based on morning serum samples.

Diver M J. Analytical and physiological factors affecting the interpretation of serum testosterone concentration in men. Ann Clin Biochem 2006; 43: 3–12

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