Beste apotheek van Nederland

C-233
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Shabsigh (2004)
242
Funding
source:
Solvay
Pharmaceuticals
Inc.
N screened = 354
N randomized = 75
IG, n = 39 (ITT, n=37)
CG, n = 36 (ITT, n=33)
ITT analysis used for
primary outcome: yes
Inclusion: men 18-80 y, with
ED of 3 mo or longer, in a
stable sexual relationship with
a female > 6mo, morning
serum total T of 400ng/dl or
less at screening visits,
nonresponders to Sildenafil
monotherapy (determined by
IIEF)
Exclusion: hx of prostate or
breast cancer, clinically sign or
uncontrolled medical or
psychiatric conditions
(including DM), neurological dx
that cause ED, generalized
skin dx that would affect gel
absorption,
hyperprolactinemia, drug or
alcohol abuse, prostate dx with
concomitant urine flow rate of
less than 12 ml/s
Age, mean (sd):
57 (10), range = 26­
73 vs. 59 (9), range =
40-79 y
Race, n (%):
White 53 (71); Black
7 (9); Asian 2 (3);
Hispanic 8 (11)
Co-morbidities: NR
Previous ED
treatment: NR
BMI, mean (sd):
32 (5) vs. 31 (6)
kg/m 2
Smoking status, n
(%): 4 (11) vs. 6 (18)
Body weight: NR
Concomitant
medications: NR
Duration of ED, n
(%):
6-12 mo: 2 (5) vs. 4
(12); > 12 mo: 35
(95), vs. 29 (88)
Underlying disease,
n (%): DM 7 (19) vs.
4 (12)
Hypertension 12 (32)
vs. 13 (39);
Hpyperlipidemia 10
(27) vs. 4 (12);
Prostate dx 5 (14) vs.
1 (3)
Psychogenic ED, n
(%): 1 (3) vs. 2 (6)
Physiologic ED n,
(%): 20 (54) vs. 14
(42)
Mixed ED, n (%): 16
(43) vs. 17 (52)
IG: Testosterone gel +
Sildenafil- oral
CG: Placebo gel +
Sildenafil -oral
IG:
Dose: 1% T gel + 100
mg Sildenafil
Duration: 12 wks
Frequency: gel 1x/day +
Sildenafil as indicated
Compliance: 100%
CG:
Dose: 5 g placebo gel +
100 mg Sildenafil
Duration: 12 wks
Frequency: gel: 1/day +
Sildenafil as indicated
Compliance: 100 %
Run In period: 4 wks
Wash out period: NR
F/u duration: longer
than 12 wks (end point
not specified)
Primary outcome results:
IIEF- EF domain, mean change from
baseline: 4.4 vs. 2.1, p =0.029
IIEF-Q5: IG better than CG, (12 wk,
p=0.008, end point p=0.004)
Pts who improved at least 1 category
from baseline for IIEF-Q3 or 4, n (%):
26 (79) vs. 22 (71)
IIEF-Q3-4, n (%) with positive response:
12 wks: 19 (58) vs. 13 (42)
Endpoint: 19 (51) vs. 13 (39)
Serum T levels ▲ from baseline at 12
wks: IG, p</=0.004; IG vs. CG,
p</=0.001
Other outcomes assessed: no
correlation between serum T levels and
IIEF at endpoint; QoL
Withdrawals/drop-outs/loss to f/u, n
(%): 7 (19) vs. 5 (14)
WEAE, n: 1(3) vs. 0
TAE: 1 vs. 0; detail not reported
SAE: 0
Ascertainment of outcomes
assessed: IIEF; GAQ