A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
A Clinical Phase III, Comparative, Open, Multicenter, Prospectively, to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet, Compared to Viagra ® 50mg Tablet Coated, in the Treatment of Erectile Dysfunction of Different Etiologies
1 other identifier
interventional
78
1 country
1
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate 20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 23, 2011
March 1, 2011
4 months
March 15, 2011
March 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate a possible superiority expressed by the faster onset of action.
To evaluate a possible superiority expressed by the faster onset of action of Sildenafil Citrate 20mg Tablet Sublingual compared to Viagra ® 50mg tablet Coated in erectile dysfunction.
35 days
Secondary Outcomes (1)
Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction.
35 days
Study Arms (2)
Sildenafil Citrate 20mg Tablet Sublingual
EXPERIMENTALAdminister one tablet of Sildenafil Citrate 20 mg sublingually 10 minutes before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Viagra ® 50mg tablet Coated
ACTIVE COMPARATORAdminister one tablet of Viagra ® 50mg tablet Coated orally 1 hour before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Interventions
Administer one tablet of Sildenafil Citrate 20 mg sublingually 10 minutes before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Administer one tablet of Viagra ® 50mg tablet Coated orally 1 hour before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Eligibility Criteria
You may qualify if:
- Patients over 18 years;
- Patients with erectile dysfunction of various etiologies (organic, psychogenic and mixed) for at least 6 months;
- Patients with scores in the IIEF-5 between 13 and 24, which correspond to mild or mild to moderate;
- Relationship stable for at least 6 months;
- Patients should be kept with libido;
- Education at least 4 years;
- Do not use sildenafil, vardenafil, tadalafil, lodenafil, injection therapy or vacuum devices up to 72 hours before the screening visit;
- Functions hepatic, hematological, hormonal and renal within the following benchmarks:
- Creatinine: 0.6 to 1.10 mg / dl;
- Urea: 10 - 50mg/dl;
- TGP: up to 40 U / L;
- TGO: ≤ 34 U / L;
- Prolactin: 2.3 to 11.5 ng / ml Men
- Total Testosterone: 241 to 827 ng/100 ml - Men
- Blood glucose: 70 mg / dl and 99mg/dl.
You may not qualify if:
- Patients who have failed treatment with inhibitors of phospho-diesterase inhibitors;
- Patients undergoing radical prostatectomy;
- Patients with hypersensitivity to any component of the formula;
- Presence of genital deformities or other disorders that prevent intercourse;
- Operations prior to penile erectile dysfunction or premature ejaculation penis enlargement;
- Use of other treatments for erectile dysfunction or concomitant treatment with nitrates;
- Myocardial infarction or cerebrovascular accident (CVA) for less than 6 months;
- Heart disease or uncontrolled serious;
- Injury cord injury;
- Multiple sclerosis;
- Retinitis pigmentosa;
- Neoplasms known in business and / or treatment;
- History of severe anaphylactic reactions and disease Steven-Johnson;
- Patients who are making use of antiretrovirals;
- Any other disease or condition is not matched that in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ipiranga Hospital
São Paulo, São Paulo, 04262-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Bertero, Investigator
Hospital for State Civil Servants of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 23, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 23, 2011
Record last verified: 2011-03