CTRI/2020/01/022798
Recruiting
Phase 3
A prospective, randomized, double-blind, twoarm,active-controlled, parallel, multicentre,non-inferiority phase III clinical trial to assessthe efficacy and safety of Avanafil ascompared to Sildenafil in patients with ErectileDysfunction
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: N529- Male erectile dysfunction, unspecified
- Sponsor
- Zydus Healthcare Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •5\. Patients willing to provide written informed consent and comply with the
- •protocol requirements
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
- •5\. Patients with cardiovascular disorder like unstable angina, angina, resting or
- •postural hypotension ( \< 90/50 mmHg), uncontrolled hypertension ( \> 170/100
- •mmHg) and with a history of myocardial infarction, arrhythmia, coronary
- •revascularization in last 6 months
Outcomes
Primary Outcomes
Not specified
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