Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.

NCT01180283 | Completed Phase 4

• 1 other identifier: CRIST 002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Sixty diabetes men with erectile dysfunction from mild to severe who agree to participate is going to have medical care approximately for 16 weeks. During the first 4 weeks, patients will not receive any inhibitor of phosphodiesterase 5. In the following eight weeks, patients will receive oral lodenafil carbonate. They will complete the International Index of Erectile Dysfunction (IIEF) questionnaire in the site and answer the Sexual Encounter Profile (SEP) questions 2 and 3 and the Erection Hadness Score (EHS) after each intercourse or attempt without or using oral lodenafil cardonate 80mg. Questionnaire of adverse event is included in patient diary.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Lodenafil carbonate; Diabetes

Outcome Measures

Primary Outcomes (1)

• Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2.

  Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS.

  16 mounths

Secondary Outcomes (1)

• Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment.

  16 months

Study Arms (1)

lodenafil carbonate (Helleva®)

EXPERIMENTAL

Drug: lodenafil carbonate

Interventions

lodenafil carbonate DRUG

Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.

lodenafil carbonate (Helleva®)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes type II;
• Age from 18 to 65 years;
• Erectile dysfunction within the previous 6 months;
• Mild, moderate or severe erectile dysfunction by IIEF questionnaire;
• Stable sexual partner in the past 2 months;
• Preserved libido;
• Studied at least up to fourth grade;

You may not qualify if:

• Current beta blocker, thiazide, alpha methyldopa, antidepressants, or antiandrogen therapy intake;
• Penile prosthesis;
• Previous intolerance to sildenafil, vardenafil, tadalafil or lodenafil carbonate;
• Previous negative response to iPDE-5 correct use.;
• Penile anatomical deformities;
• Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement;
• Myocardial infarction or cerebral vascular accident within the previous 6 months;
• Severe or uncontrolled cardiac diseases;
• Spinal cord injury, multiple sclerosis, retinitis pigmentosa;
• Radical pelvic surgery and pelvic radiotherapy, including radical prostatectomy;
• Myocardial or Coronary Artery disease with cardiologist contraindication for using iPDE5;
• Cancer;
• Anaphylactic reactions or Steven-Johnson disease;
• Participation in another clinical trial within the last 2 months;
• Sexually transmitted diseases;

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead

Study Sites (3)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, 04039-004, Brazil

Location

Hospital Ipiranga

São Paulo, São Paulo, 04262-000, Brazil

Location

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus

Interventions

lodenafil carbonate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 12, 2010
• Study Start: January 1, 2009
• Study Completion: April 1, 2010
• Last Updated: August 12, 2010

Record last verified: 2010-08

Locations

BR (3)