Effect of Testofen on Erectile Function in an Adult Male Population

Launched by RDC CLINICAL PTY LTD · Jan 30, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a supplement called Testofen on erectile function in healthy adult men. Specifically, it aims to find out if Testofen can improve symptoms of erectile dysfunction (difficulty achieving or maintaining an erection), sexual function, and overall quality of life. The study will last for 12 weeks and will include three groups: two groups will receive Testofen, while one group will receive a placebo (a treatment that looks like Testofen but has no active ingredients).

To be eligible for this study, participants must be healthy men aged between 40 and 75 years who are currently in a sexual relationship and have some difficulties with erectile function. They should not be taking any other treatments for erectile dysfunction or related conditions. During the trial, participants will be asked to stick to their usual diet and exercise routines and will not be able to take part in any other clinical studies at the same time. The trial is currently recruiting participants, and those who join will help researchers learn more about how Testofen may help improve erectile function.

Gender

MALE

Eligibility criteria

• 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.