Effect of Testofen on erectile function in adult men
Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.
This study is testing whether different doses of Testofen can improve erectile function in men aged 40 to 75 who have erectile dysfunction.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Male |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT05232279 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, randomized, placebo-controlled study designed to evaluate the effects of Testofen on erectile function in adult males aged 40-75. Participants will be assigned to one of three groups: one receiving 300mg of Testofen, another receiving 600mg of Testofen, and a placebo group. The study will monitor changes in erectile function symptom severity, sexual function, and overall quality of life over a 12-week period. The trial aims to provide insights into the efficacy of Testofen as a treatment for erectile dysfunction.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male adults aged 40-75 who are currently in a sexual relationship and have reduced erectile function.
Not a fit: Patients with a history of prostate surgery, those currently receiving treatment for erectile dysfunction, or individuals with serious underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for men suffering from erectile dysfunction, potentially improving their sexual health and quality of life.
How similar studies have performed: While there have been studies on various treatments for erectile dysfunction, the specific use of Testofen in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brisbane, Queensland
- RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Amanda Rao, PhD — RDC Clinical
- Study coordinator: Amanda Rao, PhD
- Email: amanda@rdcglobal.com.au
- Phone: +61 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.