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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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Sildenafil Citrate 20mg Tablet Sublingual
Viagra ® 50mg tablet Coated
Sponsored by
Laboratório Teuto Brasileiro S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Phase III, Sildenafil Citrate Tablet Sublingual, Erectile dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ipiranga Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sildenafil Citrate 20mg Tablet Sublingual

Viagra ® 50mg tablet Coated

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.
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.

Full Information

First Posted
March 15, 2011
Last Updated
March 22, 2011
Sponsor
Laboratório Teuto Brasileiro S/A
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1. Study Identification

Unique Protocol Identification Number
NCT01321489
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratório Teuto Brasileiro S/A

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Phase III, Sildenafil Citrate Tablet Sublingual, Erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil Citrate 20mg Tablet Sublingual
Arm Type
Experimental
Arm Description
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.
Arm Title
Viagra ® 50mg tablet Coated
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate 20mg Tablet Sublingual
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Viagra ® 50mg tablet Coated
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate a possible superiority expressed by the faster onset of action.
Description
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.
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction.
Description
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.
Time Frame
35 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sidney Glina, Investigator
Phone
55 (11) 2069-9629
Email
urohi@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Bluette Sandila, Coordenator
Phone
55 (11) 2069-9629
Email
bluette.urohi@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Bertero, Investigator
Organizational Affiliation
Hospital for State Civil Servants of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ipiranga Hospital
City
Sao Paulo
ZIP/Postal Code
04262-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidney Glina, Investigator
Phone
55 (11) 2069-9629
Email
urohi@uol.com.br
First Name & Middle Initial & Last Name & Degree
Bluette Sandila, Coordenator
Phone
55 (11) 2069-9629
Email
bluette.urohi@uol.com.br
First Name & Middle Initial & Last Name & Degree
Sidney Glina, Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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