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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Laboratório Teuto Brasileiro S/A.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01321489
First received: March 15, 2011
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: Sildenafil Citrate 20mg Tablet Sublingual
Drug: Viagra ® 50mg tablet Coated
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Laboratório Teuto Brasileiro S/A:

Primary Outcome Measures:
  • Evaluate a possible superiority expressed by the faster onset of action. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 78
Study Start Date: September 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321489

Contacts
Contact: Sidney Glina, Investigator 55 (11) 2069-9629 urohi@uol.com.br
Contact: Bluette Sandila, Coordenator 55 (11) 2069-9629 bluette.urohi@uol.com.br

Locations
Brazil
Ipiranga Hospital Not yet recruiting
Sao Paulo, Brazil, 04262-000
Contact: Sidney Glina, Investigator    55 (11) 2069-9629    urohi@uol.com.br   
Contact: Bluette Sandila, Coordenator    55 (11) 2069-9629    bluette.urohi@uol.com.br   
Principal Investigator: Sidney Glina, Investigator         
Sponsors and Collaborators
Laboratório Teuto Brasileiro S/A
Investigators
Principal Investigator: Eduardo Bertero, Investigator Hospital for State Civil Servants of Sao Paulo
  More Information

No publications provided

Responsible Party: Laboratório Teuto Brasileiro S/A, Industry
ClinicalTrials.gov Identifier: NCT01321489     History of Changes
Other Study ID Numbers: TEU-SIL-05/09
Study First Received: March 15, 2011
Last Updated: March 22, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratório Teuto Brasileiro S/A:
Phase III
Sildenafil Citrate Tablet Sublingual
Erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents

ClinicalTrials.gov processed this record on August 26, 2014