CTRI/2022/03/041069Completed未知
A double-blind, randomised, placebo controlled, parallel group study to evaluate the efficacy and safety of Libidolyn�® in improving erectile function and maintain normal sexual health.
Herbalyn Lifesciences Inc0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •a. Male subjects aged 25 to 50 years in general good health having a stable female partner for past three months.
- •b. At least a 3-month history of erectile dysfunction (ED).
- •c. Are able to read, understand and provide signed informed consent.
- •d. Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 12 and less than 18 (having Moderate severity of Erectile Dysfunction) at Randomization visit.
- •e. The subjects are anticipated to have the same female sexual partner during the study, who is willing to be associated with the male subjectsââ?¬• attempts and complete study measures during the study.
- •f. Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the double-blind treatment period and for 96 hours after the end of the study.
Exclusion Criteria
- •a. Have an IIEF-EF domain score of greater than or equal to 26 at screening.
- •b. Present with ED caused by other primary disorders such as hypertension, diabetes mellitus, obesity or other untreated/inadequately treated endocrine disease including the psychogenic ED.
- •c. History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
- •d. Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
- •e. Currently receiving treatment with nitrates, cancer chemotherapy, vasodilators, drugs for neurological conditions or antiandrogens
- •f. Subjects with mental disorders including performance anxiety
- •g. History of tobacco, drug and alcohol abuse including current smoker
- •h. Subject who has participated in a clinical study within the last 30 days prior to entering this study.
- •i. Subject with hypersensitivity to any of the study products.
Investigators
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