Beste apotheek van Nederland

C-232
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Seidman (2006)
241
Funding
source: NIH
(partnership for
Gender-Specific
Medicine)
N screened = NR
N randomized = 30
IG, n = NR
CG, n = NR
ITT analysis used for
primary outcome: NR
Inclusion: men 35 or older
with MDD, and low serum T
(350 ng/dl or less)
Exclusion: bipolar illness,
schizophrenia, substance
abuse or dependence (current
or within last yr); active suicidal
ideation; or acute severe or
unstable medical illness; men
age over 50 with PSA level of
4.0 or higher or an abnormal
digital rectal exam were
excluded
Age, mean (sd): 52
(8) y
Race: NR
Co-morbidities, n
(%): NR
Previous ED
treatment: NR
Smoking status: NR
Body weight: NR
Other:
T level, mean (sd)
ng/dl
HAMD score 21 (8)
Concomitant
medications, n (%):
Duration of ED: NR
Underlying disease,
n (%): MDD in all
Psychogenic ED, n
(%): 100%
Physiologic ED, n
(%): NR
Mixed ED, n (%): NR
Other: duration of
current MDD , median
26 mo, range 4-120
mo
IG: T enanthate IM
injection
CG: placebo injection
(sesame oil)
IG:
Dose: 200 mg
Duration: 6 wks
Frequency: once/wk
Compliance: NR
CG:
Dose: NA
Duration: as IG
Frequency: as IG
Compliance: NR
Run In period: NR
Wash out period: NA
F/u duration: 6 wks
Primary outcome results:
DSPS-M section II, mean (sd):
-Full erection on awakening:
Baseline: 1.15 (1.82) vs. 1.47 (1.66)
Post tx: 2.08 (2.29) vs. 2.18 (2.0)
-Full erection on fantasy/ daydream:
baseline 1.15 (1.72) vs. 1.88 (1.86)
Post tx 1.78 (2.16) vs. 1.71 (1.83)
-Full erection on masturbation:
Baseline 1.08 (1.66) vs. 1.59 (1.91)
Post tx 1.69 (2.25) vs. 1.71 (1.90)
-Full erection during sexual activity:
Baseline 1.54 (1.94) vs. 1.18 (1.78)
Post tx 1.77 (2.17) vs. 1.53 (1.62)
-A satisfying orgasm:
Baseline 1.92 (1.44) vs. 1.82 (1.81)
Post tx 2.31 (2.06) vs. 2.06(1.44)
-Serum T level, mean:
Baseline 262.5 (8)
Post tx 981.3 vs. 297.7 ng/dl
Other outcomes assessed: no
association for changes in T level and
depressive symptoms
Withdrawals/drop-outs/loss to f/u, n
(%): 1 (3.3)
WDAE, n (%): 1 (3.3)
TAE, n (%): NR
SAE: 1 MI in CG
Ascertainment of outcomes
assessed: self reported sexual
function; HAMD; DSPS-M section II
(scale 0-8, 0=none; 8=4 or more per d)