Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

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.
    

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).
    

Intervention name(s): lodenafil carbonate
Intervention type(s): Drug
Intervention description(s): Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erectile dysfunction; Lodenafil carbonate; Diabetes