Overview
This is a double blind, randomised, placebo-controlled clinical study with a 12-week participation and 3 groups (2 active groups and 1 placebo group) designed to monitor erectile function symptom severity and the effect Testofen may have on improving erectile function, sexual function, and quality of life.
Eligibility
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.