Erectile Dysfunction MedDRA version: 8.0 Level: LLT Classification code 10061461
Conditions
Interventions
Trade Name: Viagra®
Product Name: Viagra®
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sildenafil Citrate (Approved)
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Pfizer Global Pharamceuticals, EuCAn, Pfizer Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial. 1. Subjects who have given written informed consent to participate in the study. 2. Men subjects 18 years or older. There is no upper age limit for subjects to be included into the study. 3. Documented clinical diagnosis of ED by using IIEF-EF domain with score of = 25. 4. Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Subjects with known hypersensitivity to Viagra® or any component of the study medication. 2. Subjects with resting sitting hypotension (BP170/110 mmHg) or orthostatic hypotension. 3. Subjects receiving any PDE inhibitors within 4 weeks prior to screening. 4. Subjects with severe hepatic; cirrhosis or ALT (Alanine aminotransferase) >2x upper limit of normal) and renal impairment (creatinine clearance >30mL/min) or known history of hereditary degenerative retinal disorders such as retinitis pigmentosa. 5. Subjects who for medical reasons and /or in the opinion of the investigator require starting dose of 25mg of Viagra®. 6. Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation. 7. Subjects who have had any type of radical prostatectomy, external beam radiation brachytherapy or treatment for prostate cancer. 8. Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis. 9. Subjects who are receiving concomitant treatment or who during the study are likely to start the treatment with potent CYP3A4 and CYP2C9 inhibitors (e.g. protease inhibitors ritonavir and saquinavir, ketoconazole, itraconazole, miconazole, nefazadone, claritromycin, troleandomycin erythromycin and cimetidine). 10. Subjects who are currently using any commercially available treatments or non-commercial herbal preparations for erectile dysfunction, e.g. IC injections, vacuum devices, or testosterone patches. Such treatments/devices must not be used at any time during the study. 11. Subjects who have received any investigational drug within the six weeks prior to screening or who are taking any other investigational drug concomitantly. 12. Subjects who have a medical history of major hematological, renal, vascular or hepatic abnormalities, those with psychological or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating in the study. 13. Subjects at increased risk of priapism e.g. sickle cell disease, multiple myeloma, or with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease) and myeloproliferative disorders (e.g. myeloid leukemia, polycythemia, thrombocytopenia). 14. Subjects with other forms of sexual dysfunction (e.g. retrograde ejaculation, unejaculation, painful ejaculation, premature ejaculation, hypoactive sexual desire and inhibited or absent orgasm). 15. Subjects who donated blood within 4 weeks prior to screening, or those who intend donating blood or blood products during the period of the study or within one month following completion of the study. 16. Subjects who, in the opinion of the investigator, abuse alcohol or drugs. 17. Subjects who, in the opinion of the investigator, are not likely to complete the event logs and follow study instructions. 18. Subjects who, in the opinion of the investigator, are not likely to complete the study for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of Viagra® dose titration of 50mg?100mg versus 50mg fixed dose, in men with erectile dysfunction, based on the change in subject response (score) on the Erectile Function Domain of the International Index of Erectile Function questionnaire, as measured at the beginning and at the end of double blind treatment (Visits 3 and 4).;Secondary Objective: The secondary objectives are to assess the efficacy, safety and treatment satisfaction in the two treatment arms, based on the assessments described as secondary endpoints as measured at the beginning and at the end of the double blind treatment (Visits 3 and 4).;Primary end point(s): The primary endpoint will be defined as: Change in International Index of Erectile Function Domain Score (IIEF EF Domain Score) at the end of double blind treatment, measured as the change in score between Visit 3 and Visit 4 (Visit 4 – Visit 3). The Erectile Function Domain Score is calculated as the sum of question 1-5 and 15 of the IIEF. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed