Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Wessells, (2000)
201
Companion
study (part II) 202
Study II
(organic study)
Funding
source:
N screened = NR
N randomized = 10 (cross
over)
IG/ CG= 10
Inclusion: age 18-75 y, men
with organic ED (mean
organic risk factor of 2.2)
(ED defined as the
persistent inability to obtain
and maintain erection
sufficient for sexual
satisfaction)
Exclusion:
Concurrent use of
erectogenic medications,
radical prostatectomy,
cancer-chemotherapy,
Peyronie’s disease, or other
genital anomalies
Age, mean
(range):
Part II 56.2 (37­
67) y
Co-morbidities:
NR
Previous ED
treatment, n:
intracavernous
injection; sildenafil
5; IU Pg E- IU 1
Smoking status:
smokers n=2
Body weight: NR
Other: mean
serum
testosterone level:
362 mg/ml; mean
IIEF score (items
3 and 4) 0.77 (0-2)
Concomitant
medications:
testosterone
replacement therapy
(n=3)
Duration of ED: NR
Underlying
disease, n: as study
I
Psychogenic ED:0
Physiologic ED:
100%
Mixed ED: 0
Other: see study I
IG: subcutaneous
injection Melanotan II
CG: placebo
IG1:
Dose: 0.025-0.157
mg/kg
Duration: NR
Frequency: two
injections; total
injections = 19
Compliance: 100%
CG:
Dose: placebo
Duration: NR
Frequency: as IG
Compliance: 100%
Run In period: NR
Wash out period: 48
hrs
F/u duration: 6 hrs post
injection
Other: * n=1 received
three placebo and only
one Melanotan II
injections erroneously
Primary outcome results:
Erectile activity/injection: NR (combined
results of Study I & study II 27/39 (69%)
vs. 1/41 (2.4%)
RigiScan (mean):
Erections with response (%): 63 vs. 5
Erectile events (n): 3 vs. 0.7
Total erectile duration (min): 98 vs. 25
Tip rigidity 80-100% (min): 45 vs. 2
Tip rigidity 60-79% (min): 10 vs. 1
Average tip rigidity (%): 47 vs. 6
Erectile latency (min): 8 vs. ND
Tip RAU: 59 vs. 5
Tip TAU: 29 vs. 6
IIEF- Q12 (sd), [IG (19 injections) vs.
CG (21 injections)] very low or none 6
vs. 1
Low 3 vs. 3, Moderate 5 vs. 1, High 5
vs. 0, Very high 0 vs. 0
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u:
NR
WDAE: 0
TAE: combined results for Study I & II;
n of events/total injections, (%)
Nausea: 15/39 (38) vs. 4/41 (10)
Stretch/yawn: 22/39 (56) vs. 5/41 (12)
SAE: 0
Ascertainment of outcomes
assessed: Penile rigidity by RigiScan
and visual analog scale; SD and side
effects by questionnaire
List of abbreviations: %=percent, ▲=increased, ▼=decreased, AE=adverse event, SAE=serious adverse event, BMI=body mass index, CC=controlled clinical trials,
CG=comparator/control group, ctrls=controls, DM=diabetes mellitus, E 1 IC=intracavernosal injection, ECG=electrocardiograms, ED=erectile dysfunction, EDV=enddiastolic
velocity, f/u=follow-up, FMD=flow mediated dilation, GAQ=global assessment question, GEQ=global efficacy question, grp=group/s, HbA1C=haemoglobin,
hr=hour(s), hx=history, IG=intervention group, IIEF= international index of erectile function (EF=erectile function, OF=orgasmic function, OS=overall satisfaction,
SD=sexual desire), ITT=intent-to-treat (Y = yes, N = no, NR = not reported), IU=intraurethral, kg=kilograms, lbs=pounds, LUTS=lower urinary tract symptoms, M=male,
max=maximum, mo=month(s), NA=not applicable, PADAM=partial androgen deficiency of the aging male, PgE 1 =Prostagladin, PRL=prolactin, PSA=prostate-specific
antigen, RAU=rigidity activity unit, RCT=randomized control trial, SBP=systolic blood pressure, sign.=significant; TAE=total adverse events, TAU=tumescence activity
unit, vs.=versus, WDAE=withdrawals resulting from adverse events, wk=week(s), yr=year(s).
C-194