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

August 10, 2010 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.

Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, fixed dose, open label study.

The run in period from inclusion to conclusion will be between fourteen and sixteen weeks.

Visit zero (Vo):

  • Patients will sign the informed consent form;
  • Investigator will clinically evaluate the subjects regarding eligibility criteria;
  • Safety laboratory tests will be perform ;
  • Patients will answer the erectile function domain of the International Index of Erectile Function (IIEF);

Study coordinator:

Will orientate subjects regarding the follow:

  • Patients will not use any phosphodiesterase- 5 inhibitor (iPDE-5) for four weeks;
  • When intercourse or attempt happen, subjects will fill a diary;

Patients' diary includes: questions 2 and 3 of Sexual Encounter Profile (SEP), the Erectile Hardness Score (EHS) and adverse events data.

Subject will return after four weeks.

Visit One (V1):

  • Patients will answer basal IIEF;
  • Investigator will inform to patient the laboratory tests results;

Study coordinator:

  • Will give to the patients eight pills of lodenafil carbonate;
  • Will give instructions about study medication; Patient should take one pill from six to two hours before intercourse or attempt, with or without food intake or drink. The patient will not take more than one pill daily.
  • When intercourse or attempt happen, subjects will fill out the diary; Patients' diary includes: questions 2 and 3 of Sexual Encounter Profile (SEP), the Erectile Hardness Score (EHS) and adverse events data.

Subject will return after four weeks.

Visit two (V2)

Study coordinator:

  • Will give to patient eight pills of lodenafil carbonate;
  • Will give instructions about study medication:

Patient will take one pill from six to two hours before intercourse or attempt, with or without food intake or drink. The patient will not take more than one pill daily.

- When intercourse or attempt happen, subjects will fill out the diary;

Patients' diary includes: questions 2 and 3 of Sexual Encounter Profile (SEP), the Erectile Hardness Score (EHS) and adverse events data.

Subject will return after four weeks.

Visit three (V3)

  • Patients will answer the International Index of Erectile Function (IIEF);
  • Safety laboratory will be perform ;

Visit four (V4)

- Investigator will inform to patients the laboratory tests results;

Complete medical evaluation including adverse event questions and physical examinations will be done at all visits.

Efficacy will be assessed by files of patients who complete the study and did not have protocol violation (per protocol population).

Main outcomes to measure efficacy: IIEF (questions 1 to 15), SEP question 2 (Were you able to insert your penis into your partner's vagina?), SEP question 3 (Did your erection last long enough for you to have successful intercourse?), EHS (Erection Hardness Score).

Tolerability will be assessed by files of patients intend to treat - subjects who took the study medication at least once.

Patients logs contain questions such as: Did you experience any uncomfortable symptoms?; At what time this symptoms began?; Did you take medication to relieve the symptoms?; Did you go to the hospital /or doctor's office?.

After review the logs, investigator will interview patients to fill adverse events reports. Investigator will assess the event intensity (from mild to severe) and will define the casual relationship to the study medication (definite; probable; possible; doubtful).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04262-000
        • Hospital Ipiranga
    • SP
      • São Paulo, SP, Brazil, 04039-004
        • Hospital do Servidor Publico Estadual de Sao Paulo
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • Glycated hemoglobin > 12%;
  • Testosterone < 200ng/dL;
  • Prolactin > 20ng/dL;
  • Hemoglobin < 10g/dL;
  • Leucocytes > 14.000 cel/mm3;
  • TGO > 100 U/L;
  • TGP > 100 U/L;
  • Creatina > 2 mg/dL;
  • Investigator´s opinion;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: lodenafil carbonate (Helleva®)
Drug: lodenafil carbonate
Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2.
Time Frame: 16 mounths
Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS.
16 mounths

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment.
Time Frame: 16 months

Investigator will interview patients to fill adverse events reports.

Laboratory tests results before and after lodenafil carbonate treatment will be analyzed and compared, in order to detect significant changes.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cristália Produtos Químicos Farmacêuticos Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRIST 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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