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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01321489
• Other study ID #: TEU-SIL-05/09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 15, 2011
• Last updated: March 22, 2011
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2011
• Source: Laboratório Teuto Brasileiro S/A
• Contact: Sidney Glina, Investigator
• Phone: 55 (11) 2069-9629
• Email: urohi[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Ipiranga Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório Teuto Brasileiro S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	35 days	Yes