CTRI/2020/01/022798招募中3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •6. Patients literate enough to fill the diary card and evaluation questionnaires
排除标准
- •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
- •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
研究者
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