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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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30 August 2021 |
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Main ID: |
EUCTR2005-003290-25-ES |
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Date of registration:
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04/10/2005 |
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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 multicenter, double-blind placebo controlled, fixed dose study with an open-label, flexible dose phase to assess the efficacy of Sildenafil Citrate in providing a better sexual experience including quality of erections and satisfaction in men with erectile dysfunction.
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Scientific title:
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A multicenter, double-blind placebo controlled, fixed dose study with an open-label, flexible dose phase to assess the efficacy of Sildenafil Citrate in providing a better sexual experience including quality of erections and satisfaction in men with erectile dysfunction. |
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Date of first enrolment:
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23/11/2005 |
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Target sample size:
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312 |
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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:2005-003290-25 |
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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: yes
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male subjects aged 18-65.
2.Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)
3.Stable sexual partner for the duration of the study.
4.The investigator must obtain written informed consent prior the conduct of any study related procedures.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1.Subjects with resting sitting and/or standing systolic hypotension (BP<90/50mmHg) or hypertension (BP>170/110mmHg).
2.Subjects with significant cardiovascular disease in the last 3 months, including cardiacfailure, stroke, myocardial infarction, unstable angina and symptomatic or clinically significant cardiac arrhythmias.
3.Subjects who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or an intermittent basis.
4.Subjects with any relevant clinically significant abnormalities on the screening physical examination.
5.Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].
6.Subjects who have a known hypersensitivity to sildenafil citrate or any component of the study medication; subjects who have had any previous treatment related intolerable side effects to sildenafil citrate.
7.Subjects currently taking any other commercially available drug or non-drug treatments for erectile dysfunction (i.e., intraurethral agents, prostheses, injection therapy, topical applications, herbal or alternative medications, or vacuum-assisted erection devices. Such treatments must be terminated at or before the screening visit and must not be taken at any time during the study.
8.Subjects with any severity of hepatic impairment, severe renal impairment, a known history of retinitis pigmentosa or with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
9.Subjects who are currently being treated with or are likely to be prescribed alpha blocker medications.
10.Subjects, due to the possible dose of 100 mg sildenafil citrate in this study, who are receiving concomitant treatment with potent CYP3A4 inhibitors such as ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin and cimetidine.
11.Subjects who have received any investigational drug within the six weeks prior to screening or who are taking any other investigational drugs concomitantly.
12.Subjects who have any medical (including known history of major hematological, renal, vascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating.
13.Subjects who have donated blood within 4 weeks prior to screening, or those who intend on donating blood or blood products during the period of the study or within one month following completion of the study.
14.Subjects who, in the opinion of the investigator, abuse alcohol or drugs.
15.Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason, including planned elective surgery.
Age minimum:
Age maximum:
Gender:
Female:
Male: yes
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
MedDRA version: 8.0
Level: LLT
Classification code 10061461
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Intervention(s)
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Trade Name: Viagra®
Product Name: Viagra®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sildenafil Citrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Viagra®
Product Name: Viagra®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sildenafil Citrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To evaluate the effect of sildenafil citrate versus placebo on the IIEF-EF Domain at the end of the double-blind phase.
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Primary end point(s): The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
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Secondary Objective: To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX-Q).
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Secondary ID(s)
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2005-003290-25-SE
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A1481239
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/11/2005
Contact:
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