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 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.

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Viagra ® 50mg tablet Coated; Drug: Sildenafil Citrate 20mg Tablet Sublingual

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 Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04262-000
    • Ipiranga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Laboratório Teuto Brasileiro S/A
• Investigators: Principal Investigator: Eduardo Bertero, Investigator, Hospital for State Civil Servants of Sao Paulo

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: March 15, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Phase III; Erectile dysfunction; Sildenafil Citrate Tablet Sublingual
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: TEU-SIL-05/09