Beste apotheek van Nederland

C-137
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Dula (2001) 147
Study b
Funding
source: TAP
Pharmaceuticals
Inc.
N screened = NR
N randomized = 102 (cross
over)
IG1/IG2, n = 102
ITT analysis used for
primary outcome: No
Inclusion: male with ED 3
mo or longer, in stable
sexual relationship 6 mo or
longer; controlled diabetes,
hypertension, benign
prostate hypertrophy, and
CAD
Exclusion: unable to
achieve at least 55% base
rigidity for 10 min on at least
once/ 2 nights; sign
neurological dx, endocrine,
genito/urinary or psychiatric
dx, HIV, AIDS, cancer in
remission; drug abuse,
hypersensitivity to morphine,
recent tx for ED, use of
metoclopramide Introduction
of or dose changes in
anxiolytics, serotonin
reuptake inhibitors, betablockers,
thiazide diuretics,
alpha-methyl dopa,
clonidine; penile fibrosis;
severe pyronie’s dx, or prior
penile prosthesis
Age, mean
(range):
57 (32-71) y
Race n (%):
Caucasian: 87
(85)
African-American:
9 (9)
Hispanic: 5 (5)
Other: 1 (1)
Co-morbidities, n
(%): hypertension:
35 (34)
Diabetes: 12 (12)
Benign prostatic
hypertrophy: 20
(20)
Coronary artery
disease: 12 (12)
None: 46 (45)
Previous ED
treatment: NR
Smoking status:
NR
Body weight,
mean (range):
178 (155 – 199)
kg
Concomitant
medications: NR
Duration of ED: NR
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
Other: severity of
ED, n (%)= severe
32 (31); moderate
35 (34); mild 20 (20);
not specified 15 (14)
IG1: apomorphinesublingual
IG2: apomorphinesublingual
IG1:
Dose: 3 mg
Duration: 4 wks
Frequency: minimum
twice /wk with at least 8
hr in between doses
Compliance: 78%
IG2:
Dose: 4 mg
Duration: 4wks
Frequency: as IG1
Compliance: 78%
Run In period: 2-4 wks
Wash out period: 24­
96 hrs
F/u duration: NR
Primary outcome results:
Percentage of attempts resulting in
erection firm enough for intercourse
49% vs. 50%
Other outcomes assessed:
Proportion of attempts culminating in
successful intercourse
Withdrawals/drop-outs/loss to f/u:
NR
WDAE: NR
TAE, n (%): AE reported by 5% or more
of pts= 23/90 (26) vs. 51/92 (55);
included nausea 3 (3) vs. 13 (14);
yawning 8 (9) vs. 12 (13); dizziness 2
(2) vs. 5 (5); somnolence 5 (6) vs. 9
(10); headache 4 (4) vs. 6 (7);
vasodilatation 1 (1) vs. 6 (7)
SAE: 0
Ascertainment of outcomes
assessed: RigiScan, pts diaries, IIEF,
Brief Sexual Function Inventory