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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Laboratório Teuto Brasileiro S/A.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Laboratório Teuto Brasileiro S/A
Information provided by:
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01321489
First received: March 15, 2011
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Sildenafil Citrate 20mg Tablet Sublingual Drug: Viagra ® 50mg tablet Coated |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Laboratório Teuto Brasileiro S/A:
Primary Outcome Measures:
- Evaluate a possible superiority expressed by the faster onset of action. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 78 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sildenafil Citrate 20mg Tablet Sublingual
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.
|
Drug: Viagra ® 50mg tablet Coated
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.
|
|
Active Comparator: Viagra ® 50mg tablet Coated
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.
|
Drug: Sildenafil Citrate 20mg Tablet Sublingual
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321489
Contacts
| Contact: Sidney Glina, Investigator | 55 (11) 2069-9629 | urohi@uol.com.br |
| Contact: Bluette Sandila, Coordenator | 55 (11) 2069-9629 | bluette.urohi@uol.com.br |
Locations
| Brazil | |
| Ipiranga Hospital | Not yet recruiting |
| Sao Paulo, Brazil, 04262-000 | |
| Contact: Sidney Glina, Investigator 55 (11) 2069-9629 urohi@uol.com.br | |
| Contact: Bluette Sandila, Coordenator 55 (11) 2069-9629 bluette.urohi@uol.com.br | |
| Principal Investigator: Sidney Glina, Investigator | |
Sponsors and Collaborators
Laboratório Teuto Brasileiro S/A
Investigators
| Principal Investigator: | Eduardo Bertero, Investigator | Hospital for State Civil Servants of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Laboratório Teuto Brasileiro S/A, Industry |
| ClinicalTrials.gov Identifier: | NCT01321489 History of Changes |
| Other Study ID Numbers: | TEU-SIL-05/09 |
| Study First Received: | March 15, 2011 |
| Last Updated: | March 22, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Laboratório Teuto Brasileiro S/A:
|
Phase III Sildenafil Citrate Tablet Sublingual Erectile dysfunction |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Citric Acid Sildenafil Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013