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

Phase 3

• Conditions: Erectile Dysfunction
• Interventions: Drug: Viagra ® 50mg tablet Coated; Drug: Sildenafil Citrate 20mg Tablet Sublingual

• Registration Number: NCT01321489
• Lead Sponsor: Laboratório Teuto Brasileiro S/A

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.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-22
• Last Update Submitted: 2011-03-22
• Study First Posted: 2011-03-23
• Last Update Posted: 2011-03-23
• Study Start: 2011-09
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil Citrate 20mg Tablet Sublingual	Viagra ® 50mg tablet Coated	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	Sildenafil Citrate 20mg Tablet Sublingual	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 Measures

Name	Time	Method
Evaluate a possible superiority expressed by the faster onset of action.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction.	35 days	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.

Trial Locations

Locations (1)

Ipiranga Hospital; 🇧🇷 Sao Paulo, Brazil