CTRI/2017/03/008014已完成3 期
A Multicentric, Double Blind, Randomized, Active Control, parallel, non-inferiority Clinical study to evaluate Efficacy, Safety of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of erectile dysfunction.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 18
- 主要终点
- •To demonstrate efficacy of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of Erectile Dysfunction (ED) as demonstrated by the Index of Erectile Function (IIEF - 5) score.
研究概览
简要总结
This study is A Multicentric, Double Blind, Randomized, Active Control, parallel, non-inferiority Clinical study to evaluate Efficacy, Safety of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of erectile dysfunction.
Primary objective of the study is to assess the mean change in IEFF-5 Score from baseline to end of study.
Secondary outcome of the study are as follows;
1. Assessment of Percentage Changes in the proportion of population in the linear categories of IIEF - 5 domain score at 4, 8, 12 weeks.
2. Assessment of Percentage Change in Success of Erection Maintenance throughout the intercourse from Baseline to the end of study.
3. Assessment of Percentage Change in Ability to Ejaculate from Baseline to the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subjects who have provided their written informed consent.
- •2.Subjects between the age of 21 and 65 (both inclusive) 3.Subjects with heterosexual relationship, with history of normal sexual function.
- •4.History of Erectile Dysfunction for at least 4 weeks.
- •5.Subjects meeting with diagnostic criteria for erectile dysfunction as per the simplified international index of erectile function (IIEF-5) score lesser than 22 and more than
- •6.Penile Doppler standard systolic and diastolic velocity range for inclusions (<25 cm/sec as definite arterial dysfunction and 25-30 cm/sec as borderline case.) 7.Subjects willing to participate in the study and follow visit schedule, including response to the questions related with the sexual function information for both himself and his spouse’s and information on sexual intercourse.
排除标准
- •1.Subjects engaged in polygamy, anal penetration, and homosexual relationships.
- •2.Subjects and their female partner of the child bearing age who are not able to follow adequate contraceptive measures during the course of the study.
- •3.Subjects with history of or underlying cardiovascular condition, myocardial infarction, cardiac arrhythmia, heart failure, unstable angina, resting or postural hypotension or hypertension (Uncontrolled Hypertension 180/100 mmHg).
- •4.Primary hypoactive sexual desire, Spinal cord injury, Pelvic surgery Presence of penile anatomical abnormalities 5.Subjects for whom sexual activity is inadvisable because of their underling disease status.
- •6.Subjects having bleeding disorder.
- •7.Subjects with hereditary degenerative retinal disorders.
- •8.Subjects with history of loss of vision because of non-arteritic anterior ischemic optic neuropathy.
- •9.Subjects with abnormal laboratory values for Serum total testosterone level, Serum creatinine and Serum AST and/or ALT.
- •10.Subjects with history of cancer.
- •11.Subjects with history of chronic headache or migraine.
- •12.Subjects with History of Space occupying lesion in cranium.
- •13.Subjects with general neurasthenia, myasthenia, depression that required medical treatment, syncope or fainting episodes within 6 months of baseline visit or seizures, demyelinating neurological disorders.
- •14.Subjects with history of ototoxicity from any drug in the past or impaired hearing unless corrected surgically at least 6 months before the baseline visit.
- •15.Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. defined as FPG levels of ≥125 mg/dL and Glycosylated HbA1C Level >7%).
- •16.Subjects with history of sexually transmitted diseases, HIV infection or AIDS, Hepatitis B & C, fungus infection requiring systemic antifungal.
- •17.Subjects with a positive VDRL test 18.Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, Itraconazole or ketoconazole, clarithromycin and erythromycin.
- •19.Subjects with history of alcohol or drug abuse.
结局指标
主要结局
•To demonstrate efficacy of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of Erectile Dysfunction (ED) as demonstrated by the Index of Erectile Function (IIEF - 5) score.
时间窗: •To demonstrate efficacy of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of Erectile Dysfunction (ED) as demonstrated by the Index of Erectile Function (IIEF - 5) score.
次要结局
- Percentage Changes in the proportion of population in the linear categories((as described) of IIEF - 5 domain score at 4, 8, 12 weeks)
- Percentage Change in Success of Penetration from Baseline to the end of study.(At 4, 8, 12 weeks)
- Percentage Change in Success of Erection Maintenance throughout the intercourse from Baseline to the end of study.(At 4, 8, 12 weeks)
- Percentage Change in Ability to Ejaculate from Baseline to the end of study.(at 4, 8, 12 weeks)
研究者
研究点 (18)
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