Erectile DysfunctionPhase 3NCT01321489
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 Phase 3 study testing Sildenafil Citrate 20mg Tablet Sublingual and Viagra ® 50mg tablet Coated in people with Erectile Dysfunction, run by Laboratório Teuto Brasileiro S/A at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil Citrate 20mg Tablet Sublingual and Viagra ® 50mg tablet Coated
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Participation in a clinical study in the 2 months prior to inclusion;
- 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;
- Comorbidities such as diabetes mellitus, malignant hypertension, blood pressure (BP), systolic> 170 mmHg, diastolic BP levels> 110 mmHg, blood pressure <80 x 50 mmHg, significant cardiovascular disease, alcohol or drugs, or other disorders important.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ipiranga Hospital
São Paulo, São Paulo, 04262-000
Sidney Glina, Investigator, 55 (11) 2069-9629, urohi@uol.com.br
Bluette Sandila, Coordenator, 55 (11) 2069-9629, bluette.urohi@uol.com.br
About this study
Official title: 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
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.
Read the detailed description
Phase III clinical trial, comparative, open, multicenter, prospectively, with random inflow of 78 patients evaluable male patients with erectile dysfunction with IIEF-5 score in between 13 and 24, corresponding to mild or mild to moderate to evaluate the efficacy and safety as well as a possible superiority expressed by the faster onset of action onset of action of study medication.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil Citrate 20mg Tablet Sublingual, Viagra ® 50mg tablet Coated
- Keywords
- Phase III, Sildenafil Citrate Tablet Sublingual, Erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil Citrate 20mg Tablet SublingualDrug
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.
Viagra ® 50mg tablet CoatedDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil Citrate 20mg Tablet Sublingual | Experimental | 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. Receives: Drug: Viagra ® 50mg tablet Coated |
| Viagra ® 50mg tablet Coated | Active comparator | 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. Receives: Drug: Sildenafil Citrate 20mg Tablet Sublingual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The secondary outcame measure will be to evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in patients with Erectile Dysfunction.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório Teuto Brasileiro S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eduardo Bertero, Investigator, Principal investigator, Hospital for State Civil Servants of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321489
- Sponsor's protocol ID
- TEU-SIL-05/09
- Status last verified
- Mar 2011
- First submitted
- 15 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01321489
- Acronym / sponsor ID
- TEU-SIL-05/09
- Conditions
- Erectile Dysfunction
- Keywords
- Phase III, Sildenafil Citrate Tablet Sublingual, Erectile dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Laboratório Teuto Brasileiro S/AIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase III clinical trial, comparative, open, multicenter, prospectively, with random inflow of 78 patients evaluable male patients with erectile dysfunction with IIEF-5 score in between 13 and 24, corresponding to mild or mild to moderate to evaluate the efficacy and safety as well as a possible superiority expressed by the faster onset of action onset of action of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil Citrate 20mg Tablet Sublingual | Experimental | Drug: Viagra ® 50mg tablet CoatedAdminister 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 comparator | Drug: Sildenafil Citrate 20mg Tablet SublingualAdminister 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil Citrate 20mg Tablet SublingualAdminister 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. | Drug | Viagra ® 50mg tablet Coated |
| Viagra ® 50mg tablet CoatedAdminister 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. | Drug | Sildenafil Citrate 20mg Tablet Sublingual |
Primary outcome
Evaluate a possible superiority expressed by the faster onset of action.
Time frame: 35 days
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.
1 secondary outcome
Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction.
Time frame: 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bertero, Investigator principal investigator
Hospital for State Civil Servants of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil Citrate 20mg Tablet Sublingual and Viagra ® 50mg tablet Coated in people with Erectile Dysfunction, run by Laboratório Teuto Brasileiro S/A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidney Glina, Investigator (55 (11) 2069-9629, urohi@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate a possible superiority expressed by the faster onset of action. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011; AzTrials last refreshed its copy on 28 Oct 2026.