Beste apotheek van Nederland

C-191
C6-Subcutaneous Treatment Trials
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Rosen, RC
(2004) 199
Funding source:
NR
N screened = NR
N randomized = 25
IG1/IG2/CG, n = 25 (3 way
cross over)
ITT analysis for primary
outcomes: NR
Inclusion:
age 21-55 y; within 40% of
ideal weight, ED diagnosis
of 6 mo or longer; IIEF EF
score 16 or less; inadequate
response to 100 mg Viagra
defined by ability to attain
erection sufficient for
intercourse equal or less
than 50% of times within last
12 mo
Exclusion: Current use of
Viagra (last 4 wks prior to
enrolment); ED due to
untreated endocrine
disease, penile anatomic
deformities, prostate cancer
or radical prostatectomy;
clinically S hepatic, renal,
cardiovascular, psychiatric
or CNS disease, (i.e. stroke
or SCI)
Age, mean (sd):
48 (5), range 37­
54 y
Race, n (%):
White 19 (76),
Black 5 (20),
Hispanic 1 (4),
other 0
Co-morbidities, n
(%): DM 2 (8);
hypertension 7
(29);
hyperlipidemia 3
(12)
Previous ED
treatment: Viagra
(100 mg)
Smoking status:
11 (42%)
Body weight,
mean (sd): 97
(18) kg, range 64­
129 kg
Concomitant
medications: NR
Duration of ED,
mean (sd): 8 (5) y,
range 2-22 y
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED:
NR
IG1: subcutaneous PT­
141 low dose (+ visual
sexual stimulation)
IG2: subcutaneous PT­
141 high dose (+ visual
sexual stimulation)
CG: placebo
IG1/IG2:
Dose: 0.4 mg (IG1), 0.6
mg (IG2) injected in the
lower right quadrant of
abdomen (3 way
crossover design
always starting with
lower dose)
Duration: NA
Frequency: once/ dose,
three visits
Compliance: 100%
CG:
Dose: NA
Duration: NA
Frequency: as IG
Compliance: 100
Run In period: NA
Wash out period: 3-14
d
F/u duration: last
outcome measure taken
up to 145 min post
injection (pts were
monitored for 12 & 24 hr
post injection)
Primary outcomes (EF):
IG1 (n=24) vs. IG2 (n=21) vs. CG
(n=23), mean (SE):
Duration of rigidity, min:
>/= 60%, base: 28 (6), vs. 41 (8), vs. 6.
(2)/; tip: 19 (5) vs. 24 (6), vs. 4 (2)
>/= 80% base: 14 (4), vs. 17 (5), vs. 2
(0.6)/; tip: 5 (2), vs. 8.(3), vs. 0.4 (0.2)
RAU:
Base: 29 (5), vs. 41 (6), vs. 9 (2)
Tip: 23 (4), vs. 33 (5), vs. 7 (2)
Other outcomes assessed:
Tumescence activity untis (TAU)
Withdrawals/drop-outs/loss to f/u:
n=1 (this pts was replaced)
WDAE: n=0
TAE: 24 vs. 24 vs. 0; including nausea,
headache, vomiting, back pain,
diaphoresis, flushing, fatigue, muscle
cramps
SAE: 0
Ascertainment of outcomes
assessed: RigiScan TM; Rigidity
Assessment System
(Pharmacokinetic data, 3)
Other: pts with severe ED (IIEF- EF
score 6-10) (n=10): 6 mg PT-141
resulted in mean duration of >/= 60 and
>/=80% base rigidity of 36 and 15 min
(p<0.01) respectively compared to 8
and 2 min after placebo