1. the link between dysfuction - dr
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THE LINK BETWEENERECTI LE DYSFUNCTION,
TESTOSTERONE AND METABOLICSYNDROME
PIT I II MK N, PERHIM PUNAN DOKTER UMUM INDONESIA9-11 Maret 2012, Ballroom Pullman HotelNugroho Setiawan, RSUP FATMAWATI
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Testosterone deficiencysyndrome is a proven riskfactor for all the metabolicsyndrome components
All components of metabolicsyndrome are underlying
conditions for erectiledysfunction and T deficiency
Erectiledysfunction
Abdominal obesity represents a vicious circle:abdominal fat tissue reduces testosterone andtestosterone reduces the fat tissues.
Testosteronedeficiencysyndrome
Metabolicsyndrome(abdominal fat, diabetes,obesity, hypertension,dyslipidemia....)
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Metabolic
syndrome
Erectile
dysfunction
Testosteronedeficiency
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Disfungsi Ereksi
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Disfungsi Ereksi (DE) adalahketidakmampuan seorang pria yangmenetap untuk mencapai dan / atau
mempertahankan ereksi untuk sanggama yang memuaskan
Disfungsi Ereksi
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Erection Hardness Score (EHS)
Penis islarger but
not hard
Penis is hardbut not hardenough forpenetration
Penis is hardenough forpenetration
but notcompletelyhard
Penis iscompletely
hard andfully rigid
Severe ED
IIEF 6 - 10
Moderate ED
IIEF 11 - 16
Mild ED
IIEF 17 - 25
No ED
IIEF 26 - 30
Adapted from: Goldstein I , et al. N Engl J Med . 1998;338:1397-140Mullhall J P, et al. Validation of the erection hardness score . J Sex Med. 2007 Nov;4(6):1626-3
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Age and Sexual problem
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Source: MMAS, Decision Resources, Scott-Levin PDDA
Disfungsi Ereksi merupakan
masalah kita bersama
PrevalensiTotal
Pada pria 40-70 th
48% 8% Diagnosa52%
DEDE
92%60%
Diterapi
40%
Tidak
Ya
Tidakterdiagnosa
48% Sedang
19% Berat
33% Ring an
TIDAK
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Psychological Factors Influencing Male Erectile Function
Vascular Male
ErectileFunction
Neural
EndocrineHormones
Structural
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TREATMENT OPTIONS TREATMENT OPTIONS
FIRST LINE : ORAL DRUGS(sildenafil , vardenafil , tadalafil)SEX Therapy
SECOND LINE : VACUM PUMPIntra UrethaINTRACAVERNOSUM INJECTION
THIRD LINE : Prostesis Penis
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cGMP-specific protein kinase
Endothelial
cell
Guanylatecyclase
GTP cGMP
K +
Ca 2+
Decreased Ca 2+
Smooth
musclerelaxation& erection
Nitric
oxide
Smooth muscle cell
PDE5 Inhibitors: Mechanism of Action
5'GMP
PDE5
Cavernousnerve
Sexual st imulation
PDE5 Inhibitor
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Maleable penile prosthesis
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Inflatable penile prosthesis
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New PDE-5 inhibitors
Palit, V. & Eardley, I. Nat. Rev. Urol. 2010
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New Preparation of PDE-5i
Levitra ODT (orodispersible tablet)
Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. J Sex Med. 2010
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A NEW APPROACH TO MENS
HEALTHCAREIn this Event we will introduce a new approach to menshealthcare:
Treat ED and check for T
1.Men presenting with ED often require an immediatesolution to their ED
2. However, men with ED frequently have underlyingconditions which are also linked to testosteronedeficiency
3. In these men, checking testosterone levels may uncovera treatable deficiency
4. This approach has considerable benefits for mensoverall health
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SEKS HORMON ENDOGEN YANG SANGAT PENTING PADAPRIA DAN WANITA
MERUPAKAN HORMON STEROID TERBENTUK DARIKOLESTEROL
BERSIFAT LIPOFILIK DAN MUDAH BERDIFUSI
PADA PRIA 90-95 % DIHASILKAN LEYDIG SEL
DIPRODUKSI 5-7 MG/ HARI PADA PRIA
BERPENGARUH PADA: SEKS ORGAN, TULANG, OTOT,DARAH, J ARINGAN TISSUE, OTAK, KULIT, RAMBUT DANFUNGSI MENTAL
PADA WANITA SANGAT PENTING UNTUK FUNGSI SEKSUALDAN LIBIDO, SERTA PERAN PSIKOLOGIKAL WELL BEING
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ORGAN TUJUAN TESTOSTERON DAN METABOLISMENYA
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TDS
Bone mineral density Muscle mass and strengthObesity
LibidoErectile functionHematopoiesisDepressed mood Cognitive functionGeneral well-being
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Low testosterone
is associated withatherosclerosis
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Svartberg J et al. J Int Med 259: 576-582 (2006)
Cross-Sectional:
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TDS
IN ADULT MEN
Typicaltds
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(Visceral) fat suppressestestosterone production
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Obese men have lower testosterone
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Wu FCW et al. J Clin Endocrin Metab 93(7): 2737-2745 (2008)
European Male Aging Study (EMAS)Relationship between Age, BMI, and Hormones
40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79
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Central obesity: waist circumference in Europids 94 cmAsians: > 90 cm
PLUS any 2 of the following:
raised triglycerides: 1.7 mmol/L ( 150 mg/dL)reduced HDL cholesterol < 1.03 mmol/L ( < 40 mg/dL)raised blood pressure: systolic 130 mm Hg
diastolic 85 mm Hg (or treatment)raised fasting plasma glucose: 5.6 mmol/L ( 100 mg/dL)
(or type 2 diabetes)
The Metabolic Syndrome - A New World Wide Definition: IDF Consensus Group, Berlin 2005
http://www.idf.org/webdata/docs/MetSyndrome_FINAL.pdf
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Prevalence of Metabolic Syndrome in an Urban KoreanPopulation According to Modified NCP ATPI II Criteria
19.7
25.9
34.9
45.5
0
10
20
30
40
50
%
< 40 yr 40-59 yr 50-59 yr 60 and older
Oh J-Y et al. Diabetes Care 27: 2027-2032 (2004)
19.7
25.9
34.9
45.5
0
10
20
30
40
50
%
< 40 yr 40-59 yr 50-59 yr 60 and older
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Fat distributionWAIST CIRCUMFERENCE (WC)
Lowest rib
Iliac crest
Mid axillary line
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BMI and BMI are not the same...waist circumference is more accurate189 cm, 93 kg =BMI 26 190 cm, 94 kg =BMI 26
Waist circumference Waist circumference Testosterone Testosterone
> pembunuh yg tak disadari
Penumpukan lemak di sekitar perut
Kadar lemak yg >Tekanan darah >Gula darah >
Resiko penyakit jantung koroner & DM
Penumpukan lemak di sekitar perut
Kadar lemak yg >Tekanan darah >Gula darah >
Resiko penyakit jantung koroner & DM
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Indikasi untuk Penggantian Testosteron
-TDS-Kadar testosteron pada pagi hari di bawah
normal menengah- TI DAK ADA KONTRA INDIKASI
Nieschlag and Behre, Andrology, 2000, Springer
0
5
10
15
20
25
30
35
40
Hours 8 10 12 14 16 20 24 8
Acc. to Behre et al. 1992 J CEM
n m o l
/ l
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Nugroho Setiawan
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T estosteron
Testosteron total terdiri: T terikat globulin (SHBG) 60% T terikat albumin 38% T bebas 2%
Yang dapat aktif T terikat albumin dan T bebas
Yang aktif oleh enzim dapat dirubahEstradiol (aromatase)Dehidrotestosteron (5 a reduktase)
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Testosterone physiology and aging
Free T
SHBG + T SHBG + T
Free T
aging
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Perubahan hormonal terkait usia
www.get-back-on-track.comNugroho Setiawan
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Mengembalikan kadar testosteron
ke dalam kisaran normal menengah
WHO 1992, Geneva
Target Terapi Testosteron
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Contraindicatedtestosterone treatment:
carcinoma of the prostateor male mammary gland.
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40-49 50-59 60-69 70-79
%CaP
Total T
CaP Prevalence Increases as T Levels De
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Morgentaler A and Rhoden, Urology (2006)
Lower levels of total testosterone or free testosteroneare associated with an increased risk of cancer.
Risk of cancer doubled for men with TT < 250 ng/dl
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Pemeriksaan fisik
Tensi, nadi, berat badan, lingkar pinggang
Pemeriksaan colok dubur
Pertumbuhan organ seks dan tanda sekssekunder
Nugroho Setiawan
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Laboratory examination
TESTOSTERONEPSA
Optional:Hemoglobin, hematokrit
HbA1CLipid profilSHBG, estradiol, LH
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Testosterone preparations
1940
1954
1977
1992
1995
1998
20042004
2002
2004
Testosterone
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Sediaan Testosteron diIndonesia yang disetujui POMTestosterone Undecanoat capsul 40mgMesterolone tablet 25 mgTestosterone Propionat 30mg,
Testosterone Phenylpropionat 60mg,Testosterone isocaproate 60 mg,Testosterone decanoat 100mg AmpulTestosterone Undecanoat 1000 mg
ampulTestosterone gel
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Pemilihan preparat Testosteron- Sudah di setujui BPOM RI- Aman, minimal side effects , tidak toxic
tidak melalui liver / portal systemLevels within the normal range of physiological
- Comfortable ?????- Pemilihan diserahkan pada pasien dengan
menerangkan effectifitas, keamanan, carapemberian , perkiraan harga obat, resiko sideeffect, dll.
- Pemberian testosteron harus dibawah tanggung jawab dokter
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403530
25201510
5
0
6055
5045
0 2 4 6 8 10 12 14Weeks
T o t a l t e s
t o s t e r o n e n m o l
/ l
Nieschla and Behre, Androlo , 2000, S rin er
Normal range
Testosterone enanthate Testosterone undecanoate (Nebido)
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h b l d d
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Men with metabolic syndrome and testosterone deficiency receive testosterone
treatment
Improves every single factor of the metabolicsyndromeNormalisation of testosterone level about 8-9 months:
- Reduced fat mass(viseral/abdomen>> than subcutaneous / WC )
- Improves muscle mass (glucose metabolised)
Improves every single factor of the metabolicsyndromeNormalisation of testosterone level about 8-9 months:
- Reduced fat mass(viseral/abdomen>> than subcutaneous / WC )
- Improves muscle mass (glucose metabolised)
M i h b li d d
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Men with metabolic syndrome and testosterone deficiency receive testosterone
treatment Normalisation of testosterone level about
8-9 months:- Reduced glucose, insulin, HbA1c, improved
insulin sensitivity (with diet and exercisereduced HbA1c 1,2% without any anti diabeticmedication)
- Improves lipid patern (inhibit lipoprotein lipase),LDL cholesterol and triglycerides are reduced,HDL cholesterol increases.
- Reduction in both systoic and diastolic bloodressure.
Normalisation of testosterone level about8-9 months:- Reduced glucose, insulin, HbA1c, improved
insulin sensitivity (with diet and exercisereduced HbA1c 1,2% without any anti diabeticmedication)
- Improves lipid patern (inhibit lipoprotein lipase),LDL cholesterol and triglycerides are reduced,HDL cholesterol increases.
- Reduction in both systoic and diastolic bloodressure.
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TestosteroneAs a vasodilator by
Increase of endothelial nitric oxideproduction and decrese of endothelin 1.As anticoagulatory effects by
Reducing fibrinogen andplasminogen activator inhibitor 1PAI-1
As a vasodilator byIncrease of endothelial nitric oxideproduction and decrese of endothelin 1.As anticoagulatory effects by
Reducing fibrinogen andplasminogen activator inhibitor 1PAI-1
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International multicenter Post
Authorization Surveillance Study on theuse of Nebido to assess tolerability andtreatment outcomes in daily clinical
practice
IPASS-NEBIDO
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IPASS
Patients received up to 5 TU injduring an observation parameters of:
- Erectile function- Libido- Vigour/ vitality- Mood and- Ability to concentrate
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NEBIDOContaining 4 ml solution for injectioncontains 1000 mg Testosterone undecanoate
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Tracking statusCountry N Australia 164Austria 120Bulgaria 22Colombia 123Czech Republic 5Germany 68Hong Kong 14Indonesia 20Italy 148Kazakhstan 12Republic of Korea 95Macedonia 55Malaysia 21
Mexico 8Moldova 48Philippines 19Romania 80Russian Federation 122Saudi Arabia 40Singapore 31
Taiwan 15 Thailand 38UK 66Ukraine 20
Total 1354
164
120 22
123
5 68
14
20
148
12
95 55
21
8
48
19
80
122
40
31
15
38
66 20
N is equal to either n=enrolled or n=returned, whichever is greater.In this status, the n of CRFs considers that all enrolled patients started therapy and are being documented. L ikely, the truen of cases is smaller.
circle areas proportional to n patients in center/country
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Recommended treatment regimen for TU 1000 mg
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Patient demographics and baseline characteristics
Parameter
Age (years ) 49.2 13.9
Weight (kg) 86.8 17.6
Waist circumference (cm) 99.5 15.25
Previous androgen therapy n=641 (54%)injections: 37.4%, gels: 44.9%, capsules: 17.5%
Comorbidities Diabetes: 14.0%
Hypertension: 26.1%
Dyslipidemia: 22.2%
ED: 64.7%
Zitzmann M et al. Mens Health World Congress 2010.
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Summary of key safety data
Adverse events
Most common ADRs: hematocrit increased, PSAincreased and injection site pain (all
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Summary of key results of final analysis
1493 Patients enrolled (1500 planned)
1438 valid patients (safety population) 55 patients excluded due to retrospective documentation or
violation of study entry criteria
1123 (78.1%) patients completed study
First patient first visit: 30 October 2006Last patient last visit: 14 July 2010Data base lock: 1 September 2010Report final: 24 September 2010
6333 injections documented
Mean age: 49.2 years
54 % of patients were previously treated with androgens
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Change from Baseline in Sexual Desire after 90 days of Testosterone Treatment in 274 Hypogonadal Men According to Achieved Testosterone Levels (Threshold 600 ng/dL?)
Seftel AD et al. J Androl 25(6): 963-972 (2004)
0
0.5
1
1.5
2
0-300 (n=121) 300-599 (n=125) 600+ (n=28)
Chang e in daily desire score
p=0.25
p=0.0003
p
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Body Mass Index in 183 Hypogonadal Men after a total of 2,135 Injections of Nebido (maximal Treatment Duration 11 years)
k g x m - 2
p = 0.03
15
20
25
30
35
40
Baseline Nadir levelsat 5th injection(40 - 44 th week)
Mean nadir levelsafter 572 th injection
Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)
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Waist Circumference in 130 Hypogonadal Men after at least 8 Injections (total of 923 Injections) of Nebido
c m
p = 0.001
80
85
90
95
100
105
110
115
120
Baseline Nadir levelsat 5th injection(40 - 44 th week)
Mean nadir levelsafter 8 th injection
Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)
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LDL-Cholesterol in 183 Hypogonadal Men after a total of 2,135 Injections of Nebido (maximal Treatment Duration 11 years)
m
g / d L
p < 0.001
100
110120130140
150160170180
190
Baseline Nadir levelsat 5th injection(40 - 44 th week)
Mean nadir levelsafter 8th injection(max. 572 th week)
Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)
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HDL-Cholesterol in 183 Hypogonadal Men after a total o f 2,135 Injections of Nebido (maximal Treatment Duration 11 years)
m g /
d L
20
253035404550556065
70
p = 0.003
Baseline Nadir levelsat 5th injection(40 - 44 th week)
Mean nadir levelsafter 8th injection(max. 572 th week)
Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)
R i S li d Di li Bl d P ( H ) i 183
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Resting Systolic and Diastolic Blood Pressure (mm Hg) in 183Hypogonadal Men after a total of 2,135 Injections of
Nebido (maximal Treatment Duration 11 years)
Baseline 5th injection(40 - 44th week)
8th injection(max. 572 thweek)
m m / H g
p =0.003
100,0
110,0
120,0
130,0
140,0
150,0
160,0
Baseline 5th injection(40 - 44th week)
8th injection(max. 572 thweek)
p =0.001
60,0
70,0
80,0
90,0
100,0
110,0
Zitzmann M and Saad F, Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)
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Double-Blind Study by Svartberg:Reduction of fat mass by 5.7 kg, increase of muscle mass by 4.2 kg after 1 year treatmentwith Nebido
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Observational Study by Haider:Improvement of metabolic syndrome and liver
function (non-alcoholic liver steatosis) after1 year treatment with Nebido
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Median Value of Blood Glucose and Mean Total Cholesterol, LDL,HDL, and Triglycerides over the Study Period
54
56
58
60
62
H D L ( m m o l
/ L )
H D L ( m m o l
/ L )
200
220
240
260
280
300
T r i g l y c e r i d e a n
d C
h o l e s t e r o l
( m m o l
/ L )
T r i g l y c e r i d e a n
d C
h o l e s t e r o l
( m m o l
/ L )
100
110
120
130
140
G l u c o s e a n
d L D L ( m m o l
/ L )
G l u c o s e a n
d L D L ( m m o l
/ L )
begin 3 mths 6 mths 9 mths 12 mths Time
GlucoseLDL
TriglycerideCholesterolHDL
Haider A et al. Experimental Clin Endocrinol Diab, accepted (2009)
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Study by Kurbatov:Improvement of erectile function in
hypogonadal ED patients after treatment withNebido for an average of 30 weeks.9 out of 17 patients with venous leakage fullyrecovered their erectile function.
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Pilot Study by Kalinchenko:Improvement of the diabetic foot after a single
injection of Nebido
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77-year-old man, type 2 diabetes, phlegmon of left foot,osteomyelitis of the left calcaneus, critical ischemia of the leftleg before and 25 days after a single injection of Nebido
Kalinchenko S et al. Cardiovasc Diabetol 8: 19: 1-6 (2009)
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Study by Corona:Increased arterial stiffness is associated with
arteriogenic ED and hypogonadism.
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ED patients who did not respond to PDE
5 inhibitors alone, experiencedsignificant improvement in erectilefunction when treated with testosteroneand PDE 5 inhibitor.
Testosterone and Erectile Function:
Aversa A, et al. Clin Endocrinol (Oxf )2000;53:517522.Aversa A, et al., Clin Endo 2003;58:632638.Shabsigh R, et al., J Urol 004;172:658663.Shabsigh R. J Sex Med 2005;2:785792.Hwang TI-S, et al., Intl. J . Impotence. Res.2006; 18: 400-404. Yassin AA et al., J Sex Med 2006;3:727735 Yassin A Saad F Diede H. Andrologia38:61-68 (2006)
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Clinical Outcomes
www.get-back-on-track.comNugroho Setiawan
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MENINGKATKAN KUALITAS HIDUP
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Clinical Symptomatology
Usual appearance of young men
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