Beste apotheek van Nederland

C-139
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Gontero (2005)
149
Funding
source: NR
N screened = 154
N randomized = 130
IG, n = 65
CG, n = 65
ITT analysis used for
primary outcome: no
Inclusion: diabetic men
(type I and II) with hx of ED,
lasting at least 3 mo. for
which never received
treatment
Exclusion: any major
psychiatric disorder,
absence of stable partner,
penile deformities,
concomitant presence of a
neurological disease (other
than diabetes)
Age, mean (sd):
IG 56.58(10.25),
CG 56.05(9.65)
Race (%): NR
Co-morbidities:
ischemic heart
disease 17 vs. 21;
nitrates 5 vs. 7;
hypertension 44
vs. 38; cholesterol
(> 200) 22 vs. 21
Blood glucose,
mean (sd): 8 (2)
vs. 8(1.7) HbA1C
Previous ED
treatment: NA
Smoking status
(%): 34% vs. 38
Body weight: NR
Other: diabetes
(%): type I= 15 vs.
15; type II
(insulin)= 47 vs.
41
Concomitant
medications: NR
Duration of ED,
mean. (sd): 25 (26)
vs. 23(19) mo
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
Other: duration of
diabetes, mean (sd):
12 (9) vs. 11 (8) y;
Baseline IIEF-ER,
mean (sd):
responders=13 (6)
vs. 13 (5); nonresponders
13 (6)
vs. 13 (6); pts with
Erection grade 3 or
higher, (%):
responders 73 vs.
67; non-responders=
40 vs. 38
IG: apomorphine SL,
oral
CG: placebo, oral
IG:
Dose: 3 mg
Duration: 4 wks
Frequency: X1, 15 min
before sexual
intercourse, max= once
in 8-hr period
Compliance (%): nonresponders=
45%;
responders= 10% did
not take all tablets
CG:
Dose: 3 mg
Duration: 4 wks
Frequency: as IG
Compliance (%): nonresponders=
50%;
responders= 12% did
not take all tablets
Run In period: NA
Wash out period: NA
F/u duration: NA
Primary outcome results:
IIEF- EF domain: 13.8(6) vs. 13.2 (6)
IIEF- Q3 (erection sufficient for
intercourse): 2 (1) vs. 2 (1)
IIEF-Q4 (ability to maintain erection): 2
(1) vs. 2 (1) = no sign. differences for all
variables p > 0.05
IIEF-GEQ: affirmation responses 25 %,
vs. 21% (P=0.65)
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u: 0
WDAE: 0
TAE: 9% vs. 5% (nausea)
SAE: 0
Ascertainment of outcomes
assessed: IIEF-questionnaire; GEQ, 1
item (yes or no), IIEF-EF domain was
considered sign. if improved by 5 point