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Erectile Dysfunction | 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 research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Erectile Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafil Citrate 20mg Tablet SublingualAdminister 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 CoatedAdminister 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sildenafil Citrate 20mg Tablet SublingualAdminister 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 CoatedAdminister 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.

Study Status

Unknown status

Start Date: September 2011

Completed Date: January 2012

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Evaluate a possible superiority expressed by the faster onset of action.

Secondary Outcome: Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction.

Study sponsors, principal investigator, and references

Principal Investigator: Eduardo Bertero, Investigator

Lead Sponsor: Laboratório Teuto Brasileiro S/A

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01321489

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