Androgens and sexual function: a placebo-controlled, randomized, double-blind study of testosterone vs. dehydroepiandrosterone in men with sexual dysfunction and androgen deficiency

Figures & data

Table I.  Baseline patient characteristics of efficacy analysis dataset.

	TU (n = 24)	DHEA (n = 27)	Placebo (n = 28)
Age	59.0 ± 10.6	60.9 ± 12.0	60.2 ± 9.6
Married*, n (%)	19 (79.2)	23 (85.2)	26 (92.9)
BMI (kg/m^2)	31.3 ± 5.4	31.3 ± 5.4	29.7 ± 4.4
Serum T (nmol/l)	10.2 ± 4.9	9.0 ± 5.3	10.0 ± 5.5
Serum DHEA (μmol/l)	3.9 ± 2.8	2.5 ± 1.9	3.3 ± 2.0
LH (U/l)	4.6 ± 2.6	6.5 ± 4.1	5.8 ± 6.6
FSH (mUI/l)	5.6 ± 3.3	10.3 ± 8.6	9.3 ± 14.5
Prolactin (μg/l)	10.4 ± 4.3	11.0 ± 5.9	11.9 ± 12.0

All variables except married are reported as mean ± SD.

*Married or common law. Widowed and divorced are not included in this group.

Figure 1.  Flow chart of participants and their eventual disposition.

Table II.  Change in biochemical values.

	TU (n = 23)	DHEA (n = 25)	Placebo (n = 28)	p-value*
Serum T (nmol/l)	0.4 (−3.3 to 4.7)	3.5 (0.9–5.7)^†	0.2 (−0.6 to 2.0)	0.16
Serum DHEA (μmol/l)	1.7 (0.8–3.7)^‡	12.5 (4.9–17.0)^‡	−0.1 (−0.6 to 0.3)	<0.001
PSA	−0.01 (−0.13 to 0.08)	−0.01 (−0.17 to 0.08)	0.01 (−0.10 to 0.19)	0.51
FSH	−0.6 (−2.2 to 0.0)^†	−0.7 (−1.5 to 0.0)	0.25 (−0.3 to 1.7)	0.008
LH (U/l)	−0.7 (−2.5 to 0.2)	−0.5 (−1.1 to 0.8)	0.5 (−0.3 to 1.7)	0.031
Prolactin (μg/l)	0.2 (−2.9 to 2.0)	0.15 (−0.9 to 2.3)	0.0 (−2.6 to 1.9)	0.87

All changes are reported as median (Q1–Q3). Changes significant at p < 0.05 and p < 0.01 by the Wilcoxon signed rank test are denoted as ^† and ^‡, respectively.

*Kruskal–Wallis test comparing change between three groups.

Figure 2.  Serum T levels (nmol/L) before and upon completion of treatment with TU. Although T levels increased the intra- or inter-group differences were not significant.

Figure 3.  Changes in the levels of serum DHEA. There was a modest increase in the T group and a highly significant increase in the DHEA group.

Table III.  Comparison of change in IEEF and AMS*.

Variable^†	Group	Baseline	Follow-up	Adjusted change	Difference from placebo Δ
		Mean ± SD	Mean ± SD	Means (95% CI)	Means (95% CI)	p-value^‡
IIEF total	TU	33.9 ± 17.1	33.1 ± 18.8	−1.6 (−8.0 to 4.9)	−3.0 (−12.9 to 7.0)	0.73
	DHEA	31.4 ± 17.1	33.1 ± 20.1	1.5 (−4.5 to 7.6)	0.1 (−9.5 to 9.8)	0.999
	Placebo	30.5 ± 19.3	32.3 ± 20.5	1.4 (−4.5 to 7.4)
IIEF desire domain	TU	4.9 ± 1.5	5.0 ± 2.0	−0.0 (−0.8 to 0.8)	−1.0 (−2.2 to 0.3)	0.14
	DHEA	5.4 ± 1.8	5.7 ± 2.5	0.4 (−0.4 to 1.1)	−0.5 (−1.7 to 0.6)	0.48
	Placebo	5.1 ± 2.0	6.1 ± 2.1	0.9 (0.2 to 1.7) ^§
IIEF performance domain	TU	11.5 ± 7.0	11.1 ± 7.7	−0.2 (−3.0 to 2.5)	−0.9 (−5.2 to 3.3)	0.84
	DHEA	11.4 ± 7.6	11.8 ± 8.5	0.5 (−2.1 to 3.1)	−0.2 (−4.3 to 3.9)	0.99
	Placebo	10.4 ± 8.3	11.3 ± 9.1	0.7 (−1.8 to 3.2)
Aging males' symptoms (AMS)	TU	37.7 ± 8.3	34.3 ± 13.3	−4.5 (−8.7 to −0.3)^§	−0.5 (−7.0 to 6.1)	0.98
	DHEA	41.7 ± 10.2	40.3 ± 12.2	−1.1 (−5.0 to 2.8)	2.9 (−3.3 to 9.2)	0.47
	Placebo	42.3 ± 10.2	37.7 ± 10.7	−4.0 (−7.9 to −0.1)^§

*Based on 79 patients with follow-up scores.

^†Total IIEF (15 items) can range from 5 to 75 while the desire (2 items) and performance (6 items) domains can range from 2 to 10 and 1 to 30, respectively. AMS (17 items) can range from 17 when no symptoms are reported to 85 when all symptoms are reported as very severe.

^‡p-values based on analysis of covariance adjusting for baseline and adjusted by Dunnett's method for comparing to groups to a control.

^§p-value for within group change was between 0.01 and 0.05.

Figure 4.  Total IIEF score in the 3 cohorts at baseline and upon completion.

Figure 5.  Comparative scores in the desire domain of the IIEF. The differences were barely significant only in the placebo group.

Figure 6.  Erectile function domain scores of the IIEF.

Figure 7.  Changes in the AMS scores between baseline and upon completion of the trial.

Table IV.  Adam questionnaire.

Baseline	Follow-up	TU (n = 24)	DHEA (n = 27)	Placebo (n = 28)
Question 1: Do you have a decrease in libido (sex drive)?
Yes	Yes	14 (58%)	14 (52%)	20 (71%)
No	Yes	1 (4%)	0 (0%)	0 (0%)
Yes	No	7 (29%)	8 (30%)	5 (18%)
No	No	2 (8%)	5 (19%)	3 (11%)
Question 7: Are your erections less strong?
Yes	Yes	18 (75%)	20 (74%)	24 (86%)
No	Yes	1 (4%)	0 (0%)	0 (0%)
Yes	No	4 (17%)	4 (15%)	4 (14%)
No	No	1 (4%)	3 (11%)	0 (0%)

The number of patients who changed from no to yes divided by the number of patients who changed from yes to no provides odds ratio of having the condition after treatment compared to prior to treatment. All arms showed a similar trend in reduced odds of reporting the condition (p = 1.0 for both questions).

Table V.  GAQ at follow-up.

	GAQ libido (p = 0.57*)			GAQ function (p = 0.42*)
	TU (n = 24)	DHEA (n = 27)	Placebo (n = 28)	TU (n = 24)	DHEA (n = 27)	Placebo (n = 28)
Worse	0 (0.0)	1 (3.7)	0 (0.0)	0 (0.0)	1 (3.7)	0 (0.0)
No better	2 (8.3)	0 (0.0)	4 (14.3)	2 (8.3)	0 (0.0)	4 (14.3)
Slightly improved	15 (62.5)	15 (55.6)	12 (42.9)	16 (66.7)	15 (55.6)	13 (46.4)
Moderately improved	5 (20.8)	6 (22.2)	9 (32.1)	4 (16.7)	6 (22.2)	9 (32.1)
Greatly improved	2 (8.3)	4 (14.8)	3 (10.7)	2 (8.3)	4 (14.8)	2 (7.1)
Symptoms gone	0 (0.0)	1 (3.7)	0 (0.0)	0 (0.0)	1 (3.7)	0 (0.0)

*Kruskal–Wallis test.