Effect of Testofen on Erectile Function in an Adult Male Population

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RDC Clinical Pty Ltd

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.