A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
28. januar 2021 opdateret af: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis
The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien, 01323-001
- Pfizer Investigational Site
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CE
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Fortaleza, CE, Brasilien, 60430-370
- Pfizer Investigational Site
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MG
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Belo Horizonte, MG, Brasilien, 30150-260
- Pfizer Investigational Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien
- Pfizer Investigational Site
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PR
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Londrina, PR, Brasilien, 86010-010
- Pfizer Investigational Site
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SAO Paulo
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JAU, SAO Paulo, Brasilien, 17210-080
- Pfizer Investigational Site
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São Paulo
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Sorocaba, São Paulo, Brasilien, 18030-205
- Pfizer Investigational Site
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São José do Rio Preto, São Paulo, Brasilien
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Included patients had been in a stable relationship with a female partner for at least 6 months
- A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".
Exclusion Criteria:
- Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
- Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
- Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
- Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: placebo
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Placebo comparator to be given per protocol.
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Aktiv komparator: sildenafil
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oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
Tidsramme: Baseline and Week 10
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Baseline and Week 10
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)
Tidsramme: Baseline to Week 10
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Baseline to Week 10
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response to Partner's Satisfaction Questionnaire (optional)
Tidsramme: Week 10
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Week 10
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total Score of Quality of Life and erectile dysfunction questionnaire
Tidsramme: Baseline and Week 10
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Baseline and Week 10
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monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
Tidsramme: Baseline, and Weeks 2, 4, 6, and 10
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Baseline, and Weeks 2, 4, 6, and 10
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response to Question 1 of the Global Efficacy Assessment Question
Tidsramme: Week 10
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Week 10
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responses to questions of the IIEF
Tidsramme: Baseline and Week 10
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Baseline and Week 10
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2002
Studieafslutning (Faktiske)
1. april 2005
Datoer for studieregistrering
Først indsendt
31. marts 2008
Først indsendt, der opfyldte QC-kriterier
2. april 2008
Først opslået (Skøn)
7. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A1481076
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .