Erectile DysfunctionPhase 4NCT01180283
Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patients With Diabetes.
A Phase 4 study testing lodenafil carbonate in people with Erectile Dysfunction, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- lodenafil carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 3 sitesBrazil
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Hospital do Servidor Público Estadual de São Paulo
São Paulo, São Paulo, 04039-004
Hospital Ipiranga
São Paulo, São Paulo, 04262-000
About this study
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.
Read the 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).
- Conditions
- Erectile Dysfunction
- Being tested
- lodenafil carbonate
- Keywords
- Erectile dysfunction, Lodenafil carbonate, Diabetes
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lodenafil carbonateDrug
Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.
| Study group | Role | What they receive |
|---|---|---|
| lodenafil carbonate (Helleva®) | Experimental | Not described Receives: Drug: lodenafil carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 mounths
Secondary outcomes (1)
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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJan 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180283
- Sponsor's protocol ID
- CRIST 002
- Status last verified
- Aug 2010
- First submitted
- 29 Jul 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.
- ClinicalTrials.gov ID
- NCT01180283
- Acronym / sponsor ID
- CRIST 002
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Lodenafil carbonate, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Apr 2010
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lodenafil carbonate (Helleva®) | Experimental | Drug: lodenafil carbonate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lodenafil carbonateDosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter. | Drug | lodenafil carbonate (Helleva®) |
Primary outcome
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.
1 secondary outcome
Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment.
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lodenafil carbonate in people with Erectile Dysfunction, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2. (time frame: 16 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2010.