NCT05232279 Effect of Testofen on Erectile Function in an Adult Male Population
| NCT ID | NCT05232279 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | RDC Clinical Pty Ltd |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-04-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2022-04-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 severity and the effect Testofen may have on improving erectile function, sexual function, and quality of life.
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.
Contact & Investigator
Amanda Rao, PhD
PRINCIPAL INVESTIGATOR
RDC Clinical
Frequently Asked Questions
Who can join the NCT05232279 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 75 Years, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05232279 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT05232279 currently recruiting?
Yes, NCT05232279 is actively recruiting participants. Contact the research team at amanda@rdcglobal.com.au for enrollment information.
Where is the NCT05232279 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT05232279 clinical trial?
NCT05232279 is sponsored by RDC Clinical Pty Ltd. The principal investigator is Amanda Rao, PhD at RDC Clinical. The trial plans to enroll 120 participants.