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C-231 AuthorFundingN; study design; eligibilityParticipantscharacteristicsDiagnosis details Intervention OutcomesSeftel (2004) 239Companionstudy 240Fundingsource:AuxiliumPharmaceuticalsInc.N screened = NRN randomized = 406IG1, n = 99 (double blind)IG2, n = 106 (double blind)IG3, n = 102 (open label)CG, n = 99ITT analysis used forprimary outcome: YesInclusion: hypogonadal men20-80 (secondary to aging andalso normogonadotrophic) withmorning T level up to 300ng/dL (10.4 nmol/L), with oneor more symptoms of lowtestosterone (fatigue, reducedlibido, reduced sexualfunctioning, ▼ muscle mass)Exclusion: NRNote: pts with T levels of > 300were also randomized asprotocol deviations (n=15)*n of pts evaluated forfrequency of intercourse differsfrom those evaluated for SD &night time erections becauserequirement for steady sexualpartner was not a requirementfor study entry*Age, mean: 58 yRace (%): NRCo-morbidities: NRPrevious EDtreatment: NRBMI, mean: all pts 30kg/m 2Smoking status: NRBody weight, meanrange: 95-99 kgOther: Testosterone(nmol/L) all pts: 10.434.7;Mean (sd): 234 (57)vs. 232 (62) vs. 239(69) vs. 229 (80)ng/dLSexual function (likertscale), mean (sd)Baseline: 2 (1) vs. 3(1) vs. 2 (1) vs. 2 (1)Concomitantmedications: NRDuration of ED: NRUnderlying disease:primary 6%, orsecondary 94%(58-71% due to aging19-32% due tonormogonadotrophic)Psychogenic ED:NRPhysiologic ED: NRMixed ED: NRIG1: Testosterone gelIG2: Testosterone gelIG3: Testosterone patchCG: placebo gelIG1:Dose: 50 mg (n= 43titrate ▲ at 60 d)Duration: 90 dFrequency: dailyCompliance: 100%IG2:Dose: 100 mg (n=4titrated ▼at 60 d)Duration: 90 dFrequency: dailyCompliance: 100%IG3:Dose: 2 x 12.2 mgpatchesDuration: 90 dFrequency: dailyCompliance: 100%CG:Dose: NADuration: 90 dFrequency: dailyCompliance: 100%Run In period: 7 dWash out period: NRF/u duration: 30 and90 dPrimary outcome results:IG1 vs. IG2 vs. IG3 vs. CG (at 90 d)▲ SD from baseline (likert scale, meandaily score):0.5 vs. 1 vs. 0.6 vs. 0.5Pts with ▲ # of night time erections/ wk(%): 30 vs. 51 vs. 40 vs. 26 (at 30 d; nosign. difference at 90 d)Pts with ▲ in intercourse from baseline(%): 6 vs. 36 vs. 13 vs. 28% of full erection: no data (not sign)C-average Serum T, mean (sd):218 (74) vs. 315 (112) vs. 373 (145) vs.487 (213)Other outcomes assessed: change in# of d/wk with nighttime or d timeerections, former correlated with serumT levels at 30, and 90 d; mood; PSAlevelsWithdrawals/drop-outs/loss to f/u, n(%): 21 (5) due to AEWDAE, n (%): all 21 (5%); 1 vs. 5 vs.15 vs. 0TAE: NR (AE included: in IG2 vertigo;CA; depression with suicidal intent;UTI/pneumonia; hypertension; 15 in IG3due to local dermal site reactions)SAE: NRAscertainment of outcomesassessed: Self report daily diary, SD byLikert scale (0-7)
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This report is based on research co
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This document is in the public doma
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AcknowledgmentsThe authors would li
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ContentsExecutive Summary..........
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Table 17: Intra-urethral Treatment:
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Figure 63. Absolute Mean Change Fro
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associated with ED treatments. Two
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ED as a main complaint. In only one
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different formulations/modes of app
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Evidence Report
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flaccidity are no less important th
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prostatectomy, antipsychotic agents
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disease). Furthermore, there is ins
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Analytic FrameworkFigure 1. Analyti
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KQ 3. Harms of pharmaceutical treat
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Figure 2. Modified QUOROM Flow Char
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that included intervention characte
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Prevalence of Hypogonadism (Total S
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stimulation and a challenge test wi
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Overview of Trials79-84,86-88,90,91
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131,137,138,142,143,147,151,155,156
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pectoris occurred in a participant
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statistical test results for the ob
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individual Q1-Q15 items, 104,106,15
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Proportion of participants with hea
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erectile maintenance frequency, IIE
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Oral Treatments — Phosphodiestera
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Patients were instructed to take th
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Results obtained from two trials 19
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improved erections was higher in pa
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Clinically homogenous groups of pat
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Oral Treatments — Phosphodiestera
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The approximate proportion of smoke
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value was not reported). Even thoug
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Tadalafil (20 mg) versus tadalafil
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scheduled dosing regimen (90 percen
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Proportion of patients with improve
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Sublingual Treatments - Apomorphine
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been taking over the past two or fo
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apomorphine (5 and 6 mg: 38 and 49
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heterogeneity with respect to popul
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Finally, two studies reported on wh
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the second study, prolonged erectio
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Moxisylate versus placebo. One tria
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Quantitative SynthesisThere was a l
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erection” versus one placebo trea
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methods of allocation concealment.
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Prazosin (IU) versus placebo. One t
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reported adequate allocation concea
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Hormonal Treatments Literature Sear
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Harms. In the first trial, the diff
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sex with partner (scale 1-6, with =
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daily for 4 weeks followed by concu
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(MEDQoL) score (range 0-100) compar
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group (16.7, 12.5, and 8.3 percent,
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Question 3a. What Are the harms of
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Chapter 4. DiscussionThis evidence
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Question 1: What is the Clinical Ut
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Questions 2-3: What are the Benefit
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Harms. There were no obvious differ
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alone. Compared with trimix alone,
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PhentolamineEfficacy. The results i
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Question 2a-b: Do Specific Patient
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Methodological and Logistic Limitat
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Tables and Figures.Summary TablesTa
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123Study details 1 Study Design Set
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125Table 2: Prevalence of Hypogonad
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127Study Details 2 Study Design Set
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129Table 4: Prevalence of Hypogonad
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131Study Details 5 Study Design Set
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Table 7: Prevalence of Hyperprolact
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135StudyEDDetails 8 Study Design Se
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Table 10: Serious Adverse Events in
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Table 11: Efficacy Results of Tadal
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Treatment Control Relative RiskStud
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Treatment Control Relative RiskStud
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Table 14: Intracavernosal Injection
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StudyAdverse EventsTreatmentGroup%
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StudyAdverse EventsTreatment Contro
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Study / Typeof PatientsOutcome Defi
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Study ED Etiology OutcomeWilliams*1
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Physiologic:60.0 (18/30) 90.0 (27/3
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StudyAdverse EventTreatmentGroup% (
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TreatmentStudy ED Etiology Group% (
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StudyAdverse EventCavallini 1991 Pa
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Study/patient CharacteristicsGooma
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Aversa 2003Men witharteriogenicEDYa
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Study/patientCharacteristicsClopper
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Study/patientCharacteristicsOutcome
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Table 26: Testosterone Treatment: P
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McNicholas2002Patients reporting
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175Table 27: Miscellaneous Treatmen
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177Table 28: Nonarteritic Anterior
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Table 29: Penile Fibrosis in Studie
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StudyStudyDesignPatientsage range 4
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Figure 6. Improved erection (GEQ-Q1
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Figure 11. Visual disturbances (all
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Figure 16. Any adverse events (trea
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Figure 23. The mean IIEF-Q4 score:
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Figure 30. Improved erection (GEQ-Q
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Figure 37. Visual disturbances (all
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Figure 43. IIEF-EF ≥ 26 at follow
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Figure 49. Dyspepsia (all cause)Fig
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Figure 55. Serious adverse events (
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Figure 61. Mean per-patient percent
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Figure 67. Any adverse events (all-
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Figure 73. Any adverse events (all-
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in men with erectile dysfunction. J
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parameters in obese men with erecti
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comparative crossover study. Androl
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153. Shabsigh R. Efficacy of silden
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190.191.Stief C, Porst H, Saenz dT,
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treatment of men with erectile dysf
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randomized trial. J Urol 1997 Oct;1
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moderate and severe ED. Int J Impot
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349.350.351.randomized, placebo-con
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395. Moher D, Schulz KF, Altman DG.
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PSVRCTRIRIASBPSCSDSETTGTRTWMDpeak s
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dDegDept.Ff/uFHxhrHxIGMmaxminmoNANI
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30. or/24-2931. (ANIMALS not HUMAN)
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27. limit 26 to yr="1990 - 2008"28.
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5. exp clinical trials/6. random$.m
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20. or/17-1921. 16 and 2022. limit
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A systematic review of harms associ
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B-4Summary Table- Randomized Contro
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The Quality Assessment of Studies o
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AuthorFundingN; study design; eligi
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C-10 AuthorFundingN; study design;
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C-146 C5-Intracavernousal Injection
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C-202 C8-Topical Treatments of ED A
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References(1) Abdel-Naser MB, Imam
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in Colombia, Ecuador, and Venezuela
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with hypogonadal symptoms. Arch Gen
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Appendix D. Reference List of Exclu
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Akduman B, Crawford E D. The PCPT:
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Anderson R U, Wise D, Sawyer T et a
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Barbaree H E, Mewhort D J. The effe
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Crasilneck Harold B. Hypnotic techn
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De Leval J, Boca P, Youssef E et al
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Doggrell S A. Combination of finast
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Eardley I. Optimisation of PDE5 Inh
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Evans M F. Critical appraisal: Lose
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Formenti S C, Lieskovsky G, Simonea
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Gleave M, Qian J, Andreou C et al.
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Carson C C. Erectile dysfunction: E
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Glina S. Testosterone and erectile
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Kalsi J S, Bahadur G, Muneer A et a
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McMahon C G. New treatment options
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Padma-Nathan H. Efficacy and tolera
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Shabsigh R, Rajfer J, Aversa A et a
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Wincze John P, Carey Michael P. Sex
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Tan R S. Novel treatment options fo
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Gupta A, Cohen B H, Ruggieri P et a
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Anonymous. Sildenafil appears safe
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Bella A J, Brock G B. Tadalafil: A
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Curran M, Keating G. Tadalafil.[err
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Hunter R H, Joy C B, Kennedy E et a
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Kloner R A, Mitchell M, Emmick J T.
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Nurnberg H, George. Erectile Dysfun
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Porst H, Giuliano F, Glina S et al.
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Chen J, Godschalk M F, Katz P G et
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Hellstrom W J. Vardenafil: a new ap
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Webb D J, Muirhead G J, Wulff M et
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Kim J M, Joh Y D, Huh J D et al. Do
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Tariq S H, Haleem U, Omran M L et a
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Cheng E. Real-life safety and effic
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English J C, King D H C, Foley J P.
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Jackson G. Sildenafil (Viagra): New
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McMahon C G. An attempt to standard
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Wagner G, Montorsi F, Auerbach S et
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Kirby R S. Report from London. Pros
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Lexchin J. New drugs with novel the
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Mealy N E. Avanafil. Drugs of the F
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Saad F, Grahl A S, Aversa A et al.
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Sipski M, Alexander C, Guo X et al.
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Wilt T J, Fink H A. Is antidepressa
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Price D E, Cooksey G, Jehu D et al.
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Bolona E R, Uraga M V, Haddad R M e
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Anonymous. Sublingual apomorphine:
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Bouloux P. Testim 1% testosterone g
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Fein R L. Classification of sexual
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Green B G, Martin S. Clinical asses
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John H, Lehmann K, Hauri D. Intraur
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Lee W R. The role of androgen depri
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Mealy N E. Alprostadil cream. Drugs
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Pommerville P. Drug treatments for
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Saie D J, Sills E S. Hyperprolactin
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Anonymous. Study shows patients tak
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Appendix E. Additional Acknowledgme
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Appendix F. Quality AssessmentRando
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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Jadad Q-1AuthorYearJadad Q-2 Jadad
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Quality Assessment of Observational
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Appendix G. Funnel PlotsSildenafilF
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Figure G-3. Sildenafil (any dose) v
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VardenafilAny dose vs. PlaceboFigur
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Figure G-11. Vardenafil (any dose)
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Figure G-13. Tadalafil (20 mg) vs.
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20 mg vs. 10 mgFigure G-15. Tadalaf
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Appendix H. Instruments Used in the
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1 = Very dissatisfied2 = Moderately
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Appendix I. List of Unobtained Arti
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