A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel

Figures & data

Figure 1. Flow chart of subject disposition. ADR, adverse drug reaction; AMS, Aging Males’ Symptoms scale. ^aAn overall total of 337 subjects lacked AMS scores at both baseline and the 6-month visit. This number includes all those who discontinued the study in addition to the 83 who completed the study, but lacked AMS scores.

Table 1. Baseline demographics and characteristics of responders and nonresponders.

Demographic characteristics	Responders (n = 578), n (%)	Nonresponders (n = 134), n (%)	Overall population (N = 712), n (%)
Race/ethnicity	n = 573	n = 131	n = 704
White	525 (91.6)	118 (90.1)	643 (91.3)
Asian	29 (5.1)	7 (5.3)	36 (5.1)
American Indian or  Alaska Native	7 (1.2)	1 (0.8)	8 (1.1)
Black, of African   heritage/African   American	4 (0.7)	2 (1.5)	6 (0.9)
Other	8 (1.4)	3 (2.3)	11 (1.6)
Ethnicity	n = 466	n = 109	n = 575
Non Hispanic	463 (99.4)	108 (99.1)	571 (99.3)
Hispanic	3 (0.6)	1 (0.9)	4 (0.7)
Smoking status	n = 550	n = 124	n = 674
Smoker	136 (24.7)	16 (12.9)	152 (22.6)
Ex-Smoker	190 (34.5)	44 (35.5)	234 (34.7)
Nonsmoker	224 (40.7)	64 (51.6)	288 (42.7)
Age (years)	n = 563	n = 134	n = 697
Missing	15	0	15
Mean ± SD	52 ± 12	53 ± 12	53 ± 12
Median	53	54	53
Range	[18–99]	[25–86]	[18–99]
Systolic blood   pressure (mm Hg)	n = 570	n = 134	n = 704
Mean ± SD	133 ± 14	132 ± 15	133 ± 14
Median	130	130	130
Diastolic blood   pressure (mm Hg)	n = 566	n = 133	n = 699
Mean ± SD	83 ± 10	82 ± 10	82 ± 10
Median	80	80	80
Height (cm)	n = 510	n = 125	n = 635
Mean ± SD	176 ± 8	176 ± 8	176 ± 8
Median	176	176	176
Weight (kg)	n = 527	n = 126	n = 653
Mean ± SD	94 ± 15	93 ± 15	94 ± 15
Median	94	92	93
BMI (kg/m^2)	n = 510	n = 125	n = 635
Mean ± SD	31 ± 4	30 ± 4	31 ± 4
Median	31	30	31
Waist circumference (cm)	n = 541	n = 123	n = 664
Mean ± SD	107 ± 12	106 ± 13	107 ± 12
Median	106	105	106
Abdominal obesity^a	n = 543	n = 123	n = 666
	353 (65)	78 (63.4)	431 (64.7)
Elevated blood pressure^b	n = 545	n = 120	n = 665
	322 (59.1)	56 (46.7)	378 (56.8)
Metabolic syndrome^c	n = 557	n = 126	n = 683
	283 (50.8)	62 (49.2)	345 (50.5)
Type 2 diabetes	n = 574	n = 132	n = 706
	116 (20.2)	35 (26.5)	151 (21.4)
Type 1 diabetes	n = 557	n = 126	n = 683
	8 (1.4)	3 (2.4)	11 (1.6)
Reduced HDL-C^d	n = 490	n = 105	n = 595
or drug treatment  for reduced HDL-C	243 (49.6)	47 (44.8)	290 (48.7)
Elevated triglycerides^e	n = 491	n = 109	n = 600
	209 (42.6)	51 (46.8)	260 (43.3)

BMI, body mass index; HDL-C, high-density lipoprotein cholesterol; SD, standard deviation.

^aClassified as: Waist circumference ≥102 cm (non-Asian men) and ≥90 cm (Asian men).

^bClassified as: Systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥85 mm Hg, or drug treatment for hypertension.

^cPresence of metabolic syndrome based on 3 criteria (modified NCEP ATP III criteria [32]).

^d<40 mg/dL or 1.03 mmol/L.

^e≥150 mg/dL or 1.7 mmol/L.

Figure 2. Flow chart showing T data at baseline and after 6 months of treatment. CRF, case report form; T, testosterone.

Figure 3. Change in mean AMS total scores over 6 months according to responder status. AMS, Aging Males’ Symptoms scale. Error bars are standard error of mean.

Figure 4. Change in mean AMS total scores over 6 months according to age quartile. AMS, Aging Males’ Symptoms scale. Error bars are standard error of mean.

Figure 5. Change in IIEF total scores over 6 months according to responder status. IIEF, International Index of Erectile Function. Error bars are standard error of mean.

Figure 6. Changes in IIEF and MFI total scores over 6 months for the overall population (n = 712). p < 0.0001 versus baseline for all visits for both IIEF and MFI total scores. IIEF, International Index of Erectile Function; MFI, Multidimensional Fatigue Inventory. Error bars are standard error of mean.

Figure 7. Change in IIEF total scores over 6 months according to age quartile. IIEF, International Index of Erectile Function. Error bars are standard error of mean.

Figure 8. Change in mean MFI total scores over 6 months according to responder status. MFI, Multidimensional Fatigue Inventory. Error bars are standard error of mean.

Figure 9. Change in mean MFI total scores over 6 months according to age quartile. MFI, Multidimensional Fatigue Inventory. Error bars are standard error of mean.

Figure 10. Change in (a) mean BMI and (b) waist circumference over 6 months according to responder status. BMI, body mass index. Error bars are standard error of mean.

Figure 11. Changes in BMI and waist circumference values over 6 months for the overall population (n = 712). p < 0.0001 versus baseline for all visits for both BMI and waist circumference. BMI, body mass index. Error bars are standard error of mean.

Table 2. Summary of qualitative laboratory parameters for PSA, hemoglobin, and hematocrit (n = 1049).

	Baseline, n (%)	6 Months, n (%)
PSA	n = 1010	n = 799
High	8 (0.8)	7 (0.9)
Low	18 (1.8)	7 (0.9)
Not available	168 (16.6)	265 (33.2)
Normal	816 (80.8)	520 (65.1)
Missing	39	271
Hemoglobin	n = 972	n = 778
High	13 (1.3)	22 (2.8)
Low	63 (6.5)	31 (4)
Not available	180 (18.5)	223 (28.7)
Normal	716 (73.7)	502 (64.5)
Missing	77	271
Hematocrit	n = 989	n = 785
High	10 (1)	19 (2.4)
Low	52 (5.3)	23 (2.9)
Not available	243 (24.6)	263 (33.5)
Normal	684 (69.2)	480 (61.1)
Missing	60	264

PSA, prostate-specific antigen. High: above the upper limit of the reference range. Low: below the lower limit of the reference range. Normal: Within the reference range (upper and lower limits included).

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285:2486–97

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