Effect of Testofen on Erectile Function in an Adult Male Population
Sponsored by RDC Clinical Pty Ltd
About this trial
Last updated 9 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Healthy male adults aged 40-75 years - Currently in a sexual relationship - Males with reduced erectile function (Score of <25 on IIEF) - BMI ≤ 35 - Able to provide informed consent - Agree not to change current diet and exercise program while enrolled in this trial - Agree not to undertake another clinical trial while enrolled in this trial
Exclusion Criteria
- History of prostate surgery and/or trauma - Receiving/prescribed treatment for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories - Receiving/prescribed treatment to increase/decrease testosterone levels e.g. androgens/anti androgens - Receiving/prescribed treatment to increase/decrease nitrate or nitric oxide levels - Unstable or serious illness (e.g. serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, hormone production disorders)* - All current malignancies (excluding BCC) or chemotherapy and/or radiotherapy treatment for malignancy within the previous 2 years - Receiving/prescribed [e.g., Coumadin or Marevan (warfarin), heparin, dalteparin, enoxaparin) or other anticoagulation therapy (e.g., thromboembolectomy or the use of vena cava filters) - Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse - Chronic past and/or current alcohol use (>14 alcoholic drinks week) - Allergic to any of the ingredients in the active or placebo formula - Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion - Participants who have participated in any other related clinical study during the past 1 month a Any participant reporting having been told by their doctor that they have an under or over production of hormones (e.g., testosterone). *An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.