Actively Recruiting
Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial
Led by RDC Clinical Pty Ltd · Updated on 2025-07-24
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Testofen on erectile function in adult males aged 40 to 75 years who have reduced erectile function. This double-blind, randomized, placebo-controlled Phase 3 trial includes three groups: two receiving different doses of Testofen and one receiving a placebo. The study aims to monitor symptom severity related to erectile function and assess impacts on sexual function and quality of life over 12 weeks. Participants will be assigned randomly to receive either Testofen at 300mg or 600mg doses, or a placebo made of maltodextrin, all administered as two capsules once daily for 12 weeks. The study includes two active treatment groups and a placebo group, with treatments taken orally in capsule form. The trial is designed to compare the different dosages and placebo effects on erectile function and related symptoms. During the 12-week participation, erectile function will be measured using the International Index of Erectile Function (IIEF) questionnaire and the Erection Hardness Score (EHS) at baseline, week 4, week 8, and week 12. Secondary assessments include quality of life, sexual function, cardiovascular health, and body measurements. Participants will maintain their current diet and exercise routines, and safety and symptom changes will be closely monitored throughout the trial period.
CONDITIONS
Brief Title
Effect of Testofen on Erectile Function in an Adult Male Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male adults aged 40 to 75 years
- Currently in a sexual relationship
- Reduced erectile function with a score below 25 on the International Index of Erectile Function (IIEF)
- Body mass index (BMI) of 35 or less
- Able to provide informed consent
- Agree to maintain current diet and exercise routines during the trial
- Agree not to participate in another clinical trial while enrolled
You will not qualify if you...
- History of prostate surgery or trauma
- Currently receiving or prescribed treatments for erectile dysfunction (oral medications, devices, injections, suppositories)
- Receiving or prescribed treatments affecting testosterone or nitrate/nitric oxide levels
- Unstable or serious illnesses such as mood disorders, neurological disorders, kidney, liver, heart disease, diabetes, or hormone disorders
- Current malignancies (excluding basal cell carcinoma) or cancer treatment within the past 2 years
- Using anticoagulation therapies like warfarin, heparin, or related treatments
- Active smokers or users of nicotine, alcohol abuse, or drug abuse
- Chronic alcohol use exceeding 14 drinks per week
- Allergy to any ingredients in the study formulas
- Any condition making participation unsuitable per investigator opinion
- Participation in another related clinical study within the past month
- Hormone production disorders reported by a doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take daily capsules of Testofen or placebo for 12 weeks to evaluate effects on erectile function.
Visits at baseline, Week 4, Week 8, and Week 12
Trial Site Locations
Total: 1 location
1
RDC Clinical Pty Ltd
Brisbane, Queensland, Australia, 4006
Actively Recruiting
Research Team
A
Amanda Rao, PhD
D
David Briskey, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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