Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism

Figures & data

Table 1. Baseline characteristics.

		Oral testosterone undecanoate
Variable	Placebo N = 79	80 mg/day N = 78	160 mg/day N = 82	240 mg/day N = 77	Overall N = 316
Age (y)	58.4 ± 5.5	59.5 ± 6.5	58.4 ± 5.7	58.6 ± 5.7	58.7 ± 5.8
Race
Asian	2 (2.5%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (0.6%)
Caucasian	75 (94.9%)	78 (100%)	82 (100%)	77 (100%)	312 (98.7%)
Other	2 (2.5%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (0.6%)
Body mass index (kg/m^2)	27.41 ± 3.03	27.29 ± 3.44	27.52 ± 3.53	26.83 ± 3.51	27.27 ± 3.38
Prostate volume (ml)^a	32.91 ± 12.73	34.00 ± 8.52	32.94 ± 17.32	32.01 ± 10.26	32.98 ± 12.58
PSA (µg/l)	1.201 ± 0.755	1.283 ± 0.892	1.080 ± 0.765	1.024 ± 0.678	1.147 ± 0.779
IPSS-T	5.54 ± 3.57	5.96 ± 3.84	4.72 ± 3.77	6.03 ± 4.06	5.55 ± 3.83
IPSS-V^b	2.43 ± 2.50	2.86 ± 2.71	1.99 ± 2.30	2.66 ± 2.74	2.48 ± 2.57
IPSS-S^c	3.11 ± 2.19	3.10 ± 2.09	2.73 ± 2.05	3.36 ± 2.30	3.07 ± 2.16
IPSS-QoL	1.51 ± 1.30	1.63 ± 1.14	1.26 ± 1.15	1.77 ± 1.13	1.53 ± 1.19

Data are shown as mean ± standard deviation or n (%).IPSS-QoL = International Prostate Symptom Score-quality of life; IPSS-S = IPSS-storage symptoms; IPSS-T = IPSS-total symptoms; IPSS-V = IPSS-voiding symptoms; PSA = prostate specific antigen.

^aMeasured in a subset of patients: Placebo, N = 27; 80 mg/day, N = 28; 160 mg/day, N = 29; 240 mg/day, N = 26; Overall, N = 110.

^bIncludes sum of Q1 (incomplete emptying); Q3 (intermittency); Q5 (weak stream); Q6 (straining)

^cIncludes sum of Q2 (frequency); Q4 (urgency); Q7 (nocturia)

Figure 1. Mean ± standard error (SE) total International Prostate Symptom Score (IPSS) over time for testosterone undecanoate 80–240 mg/day versus placebo.

Figure 2. Mean ± standard error (SE) International Prostate Symptom Score (IPSS) quality of life subscore over time for testosterone undecanoate 80–240 mg/day versus placebo. Decrease in score = improvement.

Figure 3. Mean ± standard error (SE) International Prostate Symptom Score (IPSS) storage subscore over time for testosterone undecanoate 80–240 mg/day versus placebo.

Figure 4. Mean ± standard error (SE) International Prostate Symptom Score (IPSS) voiding subscore over time for testosterone undecanoate 80–240 mg/day versus placebo.

Table 2. Placebo-adjusted change from baseline in prostate-related measurements following treatment with testosterone undecanoate for up to 12 months (all subjects treated).

	Oral testosterone undecanoate^a
Prostate-related variables	80 mg/day	p Value^b	160 mg/day	p Value^b	240 mg/day	p Value^b
IPSS–T^c
Baseline	5.96 ± 3.84		4.72 ± 3.77		6.03 ± 4.06
CFB at Month 6	–0.90 [−2.04, 0.24]	0.123	−0.27 [−1.43, 0.88]	0.641	−1.33 [−2.47 −0.19]	0.022
CFB at Month 12	−0.47 [−1.90, 0.97]	0.523	0.39 [−1.07, 1.84]	0.599	−0.87 [−2.29, 0.55]	0.229
CFB at Endpoint	−0.76 [−2.01, 0.49]	0.234	−0.28 [−1.56, 0.99]	0.664	−1.30 [−2.55, − 0.05]	0.042
IPSS–V^d
Baseline	2.86 ± 2.71		1.99 ± 2.30		2.66 ± 2.74
CFB at Month 6	−0.76 [−1.55, 0.04]	0.061	0.03 [−0.77, 0.84]	0.936	−0.97 [−1.76, −0.18]	0.016
CFB at Month 12	−0.59 [−1.65, 0.46]	0.266	0.34 [−0.72, 1.41]	0.529	−0.63 [−1.67, 0.42]	0.238
CFB at Endpoint	−0.83 [−1.78, 0.11]	0.083	−0.04 [−1.101, 0.92]	0.933	−0.91 [−1.87, 0.04]	0.061
IPSS–S^e
Baseline	3.10 ± 2.09		2.73 ± 2.05		3.36 ± 2.30
CFB at Month 6	−0.17 [−0.82, 0.48]	0.600	−0.36 [−1.02, 0.30]	0.283	−0.40 [−1.05, 0.25]	0.228
CFB at Month 12	0.13 [−0.63, 0.89	0.737	0.05 [−0.72, 0.81]	0.904	−0.24 [−0.99, 0.51]	0.522
CFB at Endpoint	0.09 [−0.57, 0.75]	0.789	−0.11 [−0.78, 0.57]	0.752	−0.32 [−0.99, 0.35]	0.347
IPSS–QoL^f
Baseline	1.63 ± 1.14		1.26 ± 1.15		1.77 ± 1.13
CFB at Month 6	−0.28 [−0.66, 0.10]	0.152	−0.07 [−0.46, 0.32]	0.731	−0.44 [−0.82, −0.05]	0.026
CFB at Month 12	−0.08 [−0.50, 0.34]	0.695	0.15 [−0.28, 0.57]	0.492	−0.50 [−0.92, −0.09]	0.018
CFB at Endpoint	−0.15 [−0.51, 0.22]	0.431	0.06 [−0.31, 0.43]	0.744	−0.46 [−0.83, −0.09]	0.014
PSA (µg/l)
Baseline	1.28 ± 0.89		1.08 ± 0.77		1.02 ± 0.68
CFB at Month 6	−0.04 [−0.20, 0.12]	0.643	0.04 [−0.13, 0.20]	0.652	0.04 [−0.12, 0.21]	0.588
CFB at Month 12	−0.12 [−0.28, 0.04]	0.139	−0.13 [−0.29, 0.04]	0.128	−0.04 [−0.20, 0.12]	0.631
CFB at Endpoint	−0.07 [−0.23, 0.10]	0.425	−0.07 [−0.23, 0.10]	0.412	−0.03 [−0.20, 0.13]	0.712
Prostate volume (ml)
Baseline	34.00 ± 8.52		32.94 ± 17.32		32.01 ± 10.26
CFB at Month 6	−0.95 [−5.57, 3.67]	0.684	0.76 [−4.08, 5.60]	0.755	−0.40 [−5.21, 4.41]	0.868
CFB at Month 12	−4.15 [−9.45, 1.16]	0.123	1.80 [−3.79, 7.38]	0.522	−2.36 [−7.46, 2.75]	0.359
CFB at Endpoint	−4.27 [−8.80, 0.26]	0.065	1.20 [−3.58, 5.98]	0.619	−2.92 [−7.62, 1.77]	0.219

IPSS = International Prostate Symptom Score; PSA = prostate specific antigen.

^aBaseline data are shown as mean ± standard deviation; change from baseline (CFB) data are placebo–adjusted values and are shown as estimate [95% confidence interval].

^bAnalysis of variance model for change from baseline (relative to that for placebo) model included treatment, region, and treatment × region interaction terms.

^cIPSS–T = IPSS–total.

^dIPSS–V = IPSS–voiding; includes IPSS questions 1 (incomplete emptying); 3 (intermittency); 5 (weak stream); and 6 (straining).

^eIPSS–S = IPSS–storage; includes IPSS questions 2 (frequency); 4 (urgency); and 7 (nocturia).

^fIPSS–QoL = IPSS–Quality of Life.

Table 3. Number (%) and mean change from baseline in IPSS quality of life score of patients who had a clinically significant improvement, no clinically significant change, or clinically significant deterioration from baseline in IPSS total score at study endpoint.

			Oral testosterone undecanoate
	Placebo N = 73		80 mg/day N = 73		160 mg/day N = 67		240 mg/day N = 72
Change from baseline in IPSS-T at study endpoint	n (%)	Mean (SD) change from baseline in IPSS-QoL^a	n (%)	Mean (SD) change from baseline in IPSS-QoL^a	n (%)	Mean (SD) change from baseline in IPSS-QoL^a	n (%)	Mean (SD) change from baseline in IPSS-QoL^a
Clinically significant improvement (≥4-point decrease) from baseline	8 (11.0%)	−1.13 (1.46)	9 (12.3%)	−0.67 (1.00)	7 (10.4%)	−1.00 (1.00)	13 (18.1%)	−1.31 (0.95)
No clinically significant change (change of 0-4 points) from baseline	52 (71.2%)	−0.08 (0.99)	53 (72.6%)	−0.42 (1.01)	48 (71.6%)	−0.15 (0.95)	52 (72.2%)	−0.42 (1.07)
Clinically significant deterioration (≥4-point increase) from baseline	13 (17.8%)	0.38 (0.96)	11 (15.1%)	0.82 (1.47)	12 (17.9%)	0.92 (1.24)	7 (9.7%)	−0.14 (1.21)

IPSS-QoL = International Prostate Symptom Score-quality of life; IPSS-T = IPSS-total symptom; SD = standard deviation.

^aLower IPSS-QoL score = better QoL.

Figure 5. Mean ± standard error (SE) prostate serum antigen (PSA) over time for testosterone undecanoate 80–240 mg/day versus placebo.

Figure 6. Mean ± standard error (SE) prostate volume over time for testosterone undecanoate 80–240 mg/day versus placebo.