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

NCT01180283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2010-08-12

No results posted yet for this study

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

Interventions

DRUG

lodenafil carbonate

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

Sponsors & Collaborators

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Completion
2010-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180283 on ClinicalTrials.gov