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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.
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):
Study coordinator:
Will orientate subjects regarding the follow:
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):
Study coordinator:
Subject will return after four weeks.
Visit two (V2)
Study coordinator:
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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lodenafil carbonate (Helleva®) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lodenafil carbonate | Drug | Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil | ||
| Hospital do Servidor Público Estadual de São Paulo |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C532120 | lodenafil carbonate |
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| São Paulo |
| São Paulo |
| 04039-004 |
| Brazil |
| Hospital Ipiranga | São Paulo | São Paulo | 04262-000 | Brazil |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |