NEW STUDY ANNOUNCEMENT

Male Reduced Erectile Function Study

Are you looking to improve your erectile function?

MIgraine Study

If you are aged between 40 and 75 years and are experiencing reduced erectile function, you could help assess the effectiveness of a new herbal product.

Thank you for your interest in a new study being conducted by RDC Clinical which is evaluating the effectiveness of a herbal extract (in capsule form) on male erectile function. We are looking for healthy males aged 40-75 years that are living in Brisbane (or surrounds).

If you are having issues with erectile function (such as strength or frequency) we would love to hear from you. You can make a difference by helping to investigate a more natural alternative for improving erectile function without the use of more common pharmacological therapies.

How long is the study, and when does it start?

To make timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that the start date is flexible. Your involvement in this study will be 12 weeks and you will be required to come into our clinic at the beginning and end of the study.

Please see below for more information. You can find the eligibility and registration form on this page.

About the product you’ll help test…

The investigational product is a commercially available capsule-form extract of the Fenugreek plant (Testofen). Previous research has shown the product to have beneficial effects on male physiology and sexual function. All clinical studies, to date, found the product to be safe for use with no serious adverse effects associated with its oral administration. This study aims to investigate the efficacy of this Fenugreek extract in improving erectile function, including function and frequency, sexual frequency, satisfaction, and relationship quality in healthy males aged between 40 and 75 years.

The natural herbal extract will be taken as either a 300mg or 600mg daily dose in capsule form.

As this study is placebo-controlled, you may or may not be allocated fenugreek. 33% of participants will be assigned the placebo which is maltodextrin (a harmless inactive substance typically used as an additive in food production).  During the study period, neither you nor the study investigators will know which product you have been allocated.

Why is this study being conducted?

Several drug therapies have been developed over the years for men with a diagnosis of erectile dysfunction. Whilst effective, these drugs are often associated with several adverse effects and can have potential drug to drug interactions. There is limited research into safer and less potent pharmaceuticals, especially for men with reduced erectile functioning that is not severe enough to be clinically diagnosed but has a substantial impact on quality of life. 

What is required of participants?

The study will involve approximately 120 men aged between 40 and 75 years. Your involvement in the study will be 12 weeks. During this time, you will be asked to take 2x capsules daily and complete a number of assessments so that we can collect data during the study.

Assessments will involve the completion of online questionnaires about your health and erectile function, anthropometric measurements (blood pressure, height, weight, and waist circumference), 2x non-invasive Femoral Artery (thigh) Doppler scans and 2x fasted blood tests taken from your arm. 

You can complete the online questionnaires at home, but you will be required to attend the RDC Clinic as well as a radiology clinic at the beginning and end of the study for the scan and blood test. 

The information we collect during the study will enable the investigators to assess the product’s effectiveness on increasing erectile functioning over the 12-week study period. 

Payment 

You will be eligible for a $150 reimbursement to cover your time and any out-of-pocket expenses incurred in attending clinic visits. The payment will be made via direct deposit to your nominated bank account once all study requirements (12 weeks participation) have been met.

If you are a healthy adult and would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

Check if you can take part… study participant requirements.
  • Aged between 40 and 75 years
  • Experiencing symptoms of reduced erectile function
  • Currently in a sexual relationship
  • Generally healthy with no uncontrolled serious illnesses
  • BMI ≤ 35 (please see below calculator)
  • A non-smoker
  • Willing to agree not to use other supplements or prescribed medications for Erectile Function for the duration of the trial, and within 2 weeks prior to commencing the study
  • Willing to keep your diet and exercise routine the same whilst on the study 
  • Able to commit to the study for the 12-week period

Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

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Ethics approval & privacy… you’ll be in safe, professional hands.

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2021-07-793. The study is also registered on ClinicalTrials.gov under Registration Number NCT05232279.

Trained Trial Co-ordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.