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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2005-000360-45-IT |
Date of registration:
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20/06/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A MULTICENTER, PARALLEL GROUP FLEXIBLE DOSE STUDY WITH A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED PHASE AND AN OPEN-LABEL PHASE TO EVALUATE THE QUALITY OF ERECTIONS IN MEN WITH ERECTILE DYSFUNCTION TREATED WITH SILDENAFIL CITRATE
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Scientific title:
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A MULTICENTER, PARALLEL GROUP FLEXIBLE DOSE STUDY WITH A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED PHASE AND AN OPEN-LABEL PHASE TO EVALUATE THE QUALITY OF ERECTIONS IN MEN WITH ERECTILE DYSFUNCTION TREATED WITH SILDENAFIL CITRATE |
Date of first enrolment:
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12/05/2005 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000360-45 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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Erectil Dysfunction MedDRA version: 6.1
Level: PT
Classification code 10057672
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Intervention(s)
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Trade Name: VIAGRA* 1 CPR 25 MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Trade Name: VIAGRA* 1 CPR 50 MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Trade Name: VIAGRA* 1 CPR 100 MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Main Objective:
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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