Beste apotheek van Nederland

C-186
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Vanderschueren
(1995) 194
Funding source:
NR
N screened = NR
N randomized = 210
(cross over)
IG1-3 & CG, n = 210 (NR
for dose allocations)
ITT analysis used for
primary outcome: NR
Inclusion: men with ED,
at least 4 mo in duration,
with stable responders to
PG-E1
(ED defined as inability to
achieve rigidity sufficient
for vaginal penetration)
Exclusion: cavernous
fibrosis, anatomical
deformation of the penis,
Peyronie’s disease r a hx
of priapism, major
disease, drugs that could
substantially affect the
evaluation of EF
Age, mean
(range):
53 (29-70) y
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean (range): 4.8
(0.5- 41) y
Underlying
disease: diabetes in
7%; other NR
Psychogenic ED:
36%
Physiologic ED:
28%; (vasculogenic
21%, diabetes I 7%)
Mixed ED: 15%
IG1: PgE1 new sterile
solution
IG2: PgE1 sterile
powder
IG3: PgE1 pediatri
sterile solution
Each administered in 4
doses)
CG: placebo
IG1-3:
Dose: a= 2.5, or b=5, or
c=10, or d=20 μg
Duration: NR
Frequency: one
injection of each
formulation at the
randomized dose
Compliance: NR
CG:
Dose: 0 μg PgE1
Duration: NR
Frequency: as IG
Compliance: NR
Run In period: NR
Wash out period: at
least 3 d
F/u duration: NR
Primary outcome results:Duration of
erection, mean (sd): [IG1 vs. IG2 vs.
IG3], min:
2.5 μg: 30 (9) vs. 27 (8) vs. 33 (8)
5 μg: 52 (10) vs. 68 (12) vs. 64 (12)
10 μg c: 29 (8) vs. 35 (9) vs. 35 (9)
20 μg: 52 (11) vs. 50 (10) vs. 51 (11)
CG: 0 (0) vs. 0.5 (0.5) vs. 1.6 (1.4)
% of pts with positive response
,RigiScan (>/=70% for >/= 10 min), and
clinical assessment, data extracted from
bar graph and it is approximate:
2.5 μg: RigiScan: 33 s. 27 vs. 40;
clinical assessment: 40 vs. 33 vs. 44
5 μg: RigiScan 50 vs. 48 vs. 52; clinical
assessment: 65 vs. 75 vs. 70
10 μg: RigiScan 38 vs. 48 vs. 39,
clinical assessment 50 vs. 52 vs. 63
20 μg: RigiScan 43 vs. 45 vs. 42;
clinical assessment 55 vs. 58 vs. 55
CG: RigiScan 0 vs. 2 vs. 5; clinical
assessment 0 vs. 0 vs. 5
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u: 3
(1.5%)
WDAE: n=3; severe penile pain 1
(0.5%); systemic medical events 2 (1%)
TAE: NR; AE: penile pain, IG1 9% vs.
IG2 14% vs. IG3 17% vs. CG 11%
SAE: 0
Ascertainment of outcomes
assessed: RigiScan; clinical
assessment