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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-000244-24-IT |
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Date of registration:
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15/09/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2b, multi-center, double-blind, placebo-controlled, parallel group dose response study to assess the efficacy and safety of oral UK-390,957 in men with premature ejaculation.
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Scientific title:
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A Phase 2b, multi-center, double-blind, placebo-controlled, parallel group dose response study to assess the efficacy and safety of oral UK-390,957 in men with premature ejaculation. |
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Date of first enrolment:
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13/10/2004 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000244-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group: yes
Cross over: no
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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Hungary
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Italy
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Spain
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Sweden
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Contacts
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Name:
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Email:
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Affiliation:
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Affiliation:
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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) yes
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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treatment of premature ejaculation.
MedDRA version: 6.1
Level: PT
Classification code 10036596
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Intervention(s)
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Trade Name: Inibitori selettivi della ricaptazione
Product Name: NA
Product Code: UK 390,957
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Selective serotonin reuptake inhibitors
Current Sponsor code: UK-390,957
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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2004-000244-24-SE
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A3871027
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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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