Erectile Dysfunction Clinical Trial
Official title:
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.
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).
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 | |
Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 | |
Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 |