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

This study has been completed.
Sponsor:
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01180283
First received: July 29, 2010
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: lodenafil carbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lodenafil Carbonate in the Treatment of Erectile Dysfunction in Patient With Type II Diabetes. Multicentric Study.

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • Evidence that lodenafil carbonate improves erectile function in patients with diabetes type 2. [ Time Frame: 16 mounths ] [ Designated as safety issue: No ]
    Efficacy is assessing by files of patients including questionnaires like IIEF, SEP and EHS.


Secondary Outcome Measures:
  • Adverse events in type 2 diabetes patients taking lodenafil carbonate and laboratory tests changes after this treatment. [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

    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.



Study Start Date: January 2009
Estimated Study Completion Date: April 2010
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180283

Locations
Brazil
Hospital do Servidor Público Estadual de São Paulo
São Paulo, SP, Brazil, 04039-004
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-650
Hospital Ipiranga
São Paulo, Brazil, 04262-000
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
  More Information

No publications provided

Responsible Party: Jorge Barros Afiune, CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA
ClinicalTrials.gov Identifier: NCT01180283     History of Changes
Other Study ID Numbers: CRIST 002
Study First Received: July 29, 2010
Last Updated: August 10, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Erectile dysfunction
Lodenafil carbonate
Diabetes

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on October 20, 2014