Status:
RECRUITING
Effect of Testofen on Erectile Function in an Adult Male Population
Lead Sponsor:
RDC Clinical Pty Ltd
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-75 years
Phase:
PHASE3
Brief 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 seve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05232279
Start Date
April 19 2022
End Date
June 1 2026
Last Update
July 24 2025
Active Locations (1)
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1
RDC Clinical Pty Ltd
Brisbane, Queensland, Australia, 4006