Health Condition 1: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
None listed
Sponsors
Herbalyn Lifesciences Inc
In Vitro Research Solutions iVRS Pvt Ltd
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 at 90 day Endpoint.Timepoint: Baseline to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Change From Baseline to 90 days Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score, Intercourse Satisfaction (IIEF-IS) Domain Score, Overall Satisfaction (IIEF-OS) Domain Score ââ?¬Â¢ Change From Baseline to 90 day Endpoint serum testosterone & serum prolactin. ââ?¬Â¢ Proportion of subjects with adverse events (including clinically significant abnormality in laboratory values and vital signs) ââ?¬Â¢ Subjectââ?¬â?¢s global assessment of therapy at end of the treatment visit.Timepoint: Baseline to Day 90 | — |
Countries
India
Contacts
Public ContactT Vijay Bhaskar
In Vitro Research Solutions Pvt. Ltd.
Outcome results
None listed