CTRI/2019/06/019517尚未招募2 期
A Randomized, Double Blind, Placebo Controlled study to evaluate efficacy and safety of PR/HC/1718/002 in patients suffering from sexual dysfunction. - Nil
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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.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
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