Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Yassin (2006) 245
Funding
source: NR
N screened =
N randomized = 69 (open
label randomized)
IG1, n = 35
IG2, n = 34
ITT analysis used for
primary outcome: NR
Inclusion: hypogonadal
(serum T 3.4 ngml -1 or less)
age 34-78 y, with at least 6 mo
hx of ED of any severity; hx of
no response to 6-8 attempts
with 20 mg tadalafil (poor EF
score, persistent
dissatisfaction)
Exclusion: clinically sign
disease known to contradict
with T or tadalafil; severe DM,
IPSS > 18; prostatitis,
hyperprolactinaemia (>20
ngml -1 ); CV attacks in last 6
mo
Age, mean (sd): 58.3
(9.7) vs. 59.9 (9.1) y
Race: NR
Co-morbidities, n
(%): DM type I 2 (5.9)
vs.0; DM type II 6
(17.6) vs. 5 (14.3);
hypertension 11
(32.4) vs. 13 (37.1);
dyslipidaemia 7 (20.6)
vs. 6 (17.1);
BPH/LUTS 16 (47.1)
vs. 11 (31.4)
Previous ED
treatment: all pts had
tadalafil monotherapy
Smoking status: 13
(38.2) vs. 15 (42.9)
Body weight: NR
Concomitant
medications, n (%):
NR
Duration of ED: NR
Underlying disease,
n (%):
hypogonadalism
Psychogenic ED, n
(%): 0
Physiologic ED, n
(%): 100%
Mixed ED, n (%): 0
Other:
ED severity, n (%):
midland moderate 23
(67.7) vs. 26 (74.3);
severe 12 (35.3) vs. 8
(22.9)
Mean IPSS: 15 (both
grps)
IG: sildenafil + T gel
(Testogel®)
CG: T gel alone
IG1:
Dose: 20 m sildenafil +
5 g containing 50 mg T
Duration: 10 wks
Frequency: sildenafil
twice/wk; T gel NR
Compliance: 100%
IG2:
Dose: 5 g containing 5
mg T
Duration: 10 wks
Frequency: NR
Compliance:
Run In period: 4 wks T
gel tx
Wash out period: 2
wks (post tadalafil
Monotherapy)
F/u duration: 10 wks
Other: IG
CG were assigned to
add tadalafil to T tx at
the end of 10 wk trial
Primary outcome results:
Mean (sd), IG1 vs. IG2
IIEF-EF domain:
Baseline 11.3 (3.0) vs. 11.3 (2.8)
10 wks: 18.3 (0.2) vs. 18.2 (0.4)
(% improved in IIEF-EF with T-gel
monotherapy in IG1 wk 4 = 43% vs. IG2
at wk 10 65%)
IIEF-OF:
Baseline 5.4 (2.6)
10 wks: 7.1 (1.4) vs. 7.1 (0.3)
IIEF SD:
Baseline 6.1 (2.8)
10 wks: 8.7 (0.8) vs. 7.8 (0.9)
IIEF-IS:
Baseline 8.9 (1.6)
10 wks: 13.1 (1.4) vs. 12.8 (1.2)
IIEF-OS:
Baseline 5.0 (1.5)
10 wks 8.2 (0.4) vs. 8.6 (0.3)
Other outcomes assessed: partner
satisfaction
Withdrawals/drop-outs/loss to f/u, n
(%): NR
WDAE: 0
TAE: 0
SAE: 0
Ascertainment of outcomes
assessed: Serum hormone analysis;
IIEF; pts and partner questionnaire on
efficacy of erectile quality/rigidity
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=end-diastolic 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).
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