Beste apotheek van Nederland

C-218
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Boyanov (2003)
228
Funding
source: NR
N screened = NR
N randomized = 48 (Openlabel
trial)
IG, n = 24
CG, n = 24
ITT analysis used for
primary outcome: NR
Inclusion: Men aged 45-65 y,
type 2 DM, and symptoms of
mild androgen deficiency or
ED; in a stable relationship;
waist-hip ratio of 0.9 or
greater; low testosterone
levels (total testosterone <
15.1 nmol/l)
Exclusion: concurrent dx
other than DM, or surgical
intervention likely to impair
sexual function, amputation or
chronic renal failure, ACE
inhibitors’ use, hx of
alcoholism, prostate
enlargement or abnormalities
Age, mean (sd):
58 (5) y
Race (%): NR
Co-morbidities, (%):
peripheral or
autonomic
neuropathy or
retinopathy (50%),
CHD (17%),
nephropathy (33%)
Blood glucose,
mean (sd):
10 (2) HbA1C
Previous ED
treatment: NR
BMI, mean (sd): 31
(5) kg/m 2
Smoking status: NR
Body weight: 94 (19)
vs. 95 (20) kg
Concomitant
medications: oral
hypoglycaemic
agents in 62.5%
(metformin in 25%,
metformin +
sulphonylurea in
37.5%), insulin mono
therapy 12.5%,
hypoglycaemic
agents + insulin 25%
(metformin in 12.5%,
sulphonylurea in
12.5%); ACE
inhibitors in 35%
Duration of ED: NR
Underlying disease:
diabetes, andropause
Psychogenic ED:
NR
Physiologic ED: NR
Mixed ED: NR
Other: Mean duration
DM = 6 (1-18) y
IG: Testosterone- oral
CG: No treatment
IG:
Dose: 120 mg/d
Duration: 3 mo
Frequency: twice (80
and 40 mg)/d
Compliance: NR
CG:
Dose: NA
Duration: as IG
Frequency: NA
Compliance: NR
Run In period: NR
Wash out period: NR
F/u duration:
3 mo
Primary outcome results:
IG vs. CG, mean (sd)
IIEF (abridged 5-item version) score at
Baseline: 2 (0.7) vs. 2.5 (0.8)
3 mo: 1.1 (0.9) vs. 2 (0.9), p < 0.05
SBP (mmHg), mean (sd):
Baseline: 122 (8) vs. 120 (8);
Post tx: 120 (10) vs. 122 (8) mmHg
DBP (mmHg), mean (sd):
Baseline: 80 (4) vs. 76 (6)
Post tx: 82 (4) vs. 76 (6) mmHg
Total serum T (nmol/l), mean (sd):
Baseline: 9.6 (2.3) vs. 10.8 (3)
Post tx (10 hr post last drug
administration): 15.5 (3.4) vs. 11.2 (3.2)
Other outcomes assessed: body
weight, BMI reduction (evident in IG),
fasting blood glucose level (sign drop in
IG); serum triglyceride levels (drop in
both grps); symptoms of androgen
deficiency (nervousness, weakness,
insomnia, libido)
Withdrawals/drop-outs/loss to f/u:
NR
WDAE: 0
TAE: 0
SAE: 0
Ascertainment of outcomes
assessed: IIEF-5; SD by 4 point scale
(0-3) questionnaires