Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
Intervention1: Avanafil 100mg / 200mg Tablets: One tablet to be taken approximately 15 minutes prior to initiation of sexual activity
Control Intervention1: Sildenafil 50mg / 100mg Tablets: One tablet
Sponsors
Zydus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 21 years of age and above 2. Patients with history of erectile dysfunction (defined as inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) for at least 3 months 3. Patients meeting the diagnostic criteria for erectile dysfunction as per the international index of erectile function-Erectile Function Domain (IIEF-EF) score lesser than 26 4. Patients in heterosexual, monogamous steady relationship since last 6 months 5. Patients willing to provide written informed consent and comply with the protocol requirements 6. Patients literate enough to fill the diary card and evaluation questionnaires
Exclusion criteria
Exclusion criteria: 1. Patients engaged in polygamy and homosexual relationships 2. Patients who have used PDE5 inhibitors or any other drug for erectile dysfunction in last 4 weeks 3. Patients who have tried PDE5 inhibitors in past and have discontinued either due to lack of efficacy or significant side effects 4. Patients with known hypersensitivity to sildenafil, avanafil or other PDE5 inhibitors 5. Patients with cardiovascular disorder like unstable angina, angina, resting or postural hypotension ( 170/100 mmHg) and with a history of myocardial infarction, arrhythmia, coronary revascularization in last 6 months 6. Patients taking prohibited concomitant medication 7. Patients with history of primary hypoactive sexual desire, hypogonadism, spinal cord injury, pelvic surgery, radical prostectomy, history of or predisposition to priapism, presence of penile anatomical abnormalities, use of penile implants 8. Patients for whom sexual activity is inadvisable because of their underlying disease status 9. Patients with history of loss of vision because of non-arteritic anterior ischemic optic neuropathy 10. Patients with history of hearing loss, tinnitus, dizziness or with history of ototoxicity from any drug in the past 11. Patients having bleeding disorder 12. Patients with history of chronic headache or migraine 13. Patients with abnormal laboratory values i.e. RBS > 140mg/dl, serum transaminases >= 3 x Upper Normal Limit, serum bilirubin >= 2.0 mg/dl, serum creatinine >= 2.5 mg/dl, serum total testosterone level more than 25% below the age-adjusted lower limit of normal according to range of testing laboratory 14. Subjects with Type 1 or Type 2 Diabetes Mellitus. 15. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 16. Patients with history of sexually transmitted diseases, HIV infection or AIDS, Hepatitis B & C 17. Patients with continuing history of alcohol and/or drug abuse 18. Participation in another clinical trial in the past 3 months prior to screening 19. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF-EF domain score in the two groupsTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported during the studyTimepoint: 12 weeks;IIEF score domains other than EF in the two groupsTimepoint: 4 weeks and 12 weeks;IIEF-EF domain score in the two groups at end of 4 weeksTimepoint: 4 weeks;Overall tolerability evaluationTimepoint: 12 weeks;Percentage of patients reaching a normal IIEF-EF scoreTimepoint: 12 weeks;Percentage of sexual attempts with some erection in 15 minutes in the two groupsTimepoint: 4 weeks and 12 weeks;Percentage of successful vaginal penetration and successful intercourse in the two groupsTimepoint: 4 weeks and 12 weeks;Serious adverse events reported during the studyTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Zydus Healthcare Limited
Outcome results
None listed