CTRI/2019/06/019517尚未招募2/3 期
A Randomized, Double Blind, Placebo Controlled study to evaluate efficacy and safety of PR/HC/1718/002 in patients suffering from sexual dysfunction.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of SHL 1046 in patients suffering from erectile dysfunction by assessing
研究概览
简要总结
PR/HC/1718/002 capsules will be assesed for efficacy and safety in male erectile dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged 21-50 years suffering from ED.
- •2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
- •3.Subjects should be in an active stable sexual relationship for the entire duration of study 4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.
- •5.Subjects willing to make all required study visits.
排除标准
- •1.Subjects having anatomical abnormalities of the penis.
- •2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
- •3.Subjects with severe form of sexual dysfunction as evidenced by at least one of the following conditions, -An International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is less than 11 and greater than 25 at screening -Subjects with prior ineffective treatment with (or non-responder to) any PDE5 Inhibitor or underwent treatment for promoting spermatogenic fertility in last 3 months -Subjects with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease -History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator -Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.) 4.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.
- •5.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion- a.cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders 6.Subjects with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day.
- •7.Subjects with any clinically significant laboratory or ECG findings during screening.
- •8.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.
- •9.Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases 10.Known hypersensitivity to ingredients used in study drugs 11.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
结局指标
主要结局
To evaluate efficacy of SHL 1046 in patients suffering from erectile dysfunction by assessing
时间窗: Baseline, Day 30, Day 60, Day 90
1.Erectile function of penis on Erectile function subscale of IIEF Questionnaire
时间窗: Baseline, Day 30, Day 60, Day 90
2.Sexual desire/ Libido (IIEF questionnaire)
时间窗: Baseline, Day 30, Day 60, Day 90
次要结局
- 1.Hardness of penis(2.Subjective Vitality Score, Perceived Stress Scale,satisfaction with life score)
研究者
研究点 (1)
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