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TESTEF Screening Form

This is a 12-week study evaluating the effectiveness of Testofen on improving erectile function in adult males.
Testofen is a natural supplement that is made with a fenugreek seed extract.

As men age, sexual function can suffer. Testofen has previously demonstrated beneficial effects of male sexual function. This study aims to explore whether Testofen improves erectile function and overall quality of life in men experiencing declined erectile function.

Before we can enrol you in this study, we'll ask you some screening questions, send you a consent form, and ask you to complete a questionnaire on Erectile Function. Once we get your results, we can determine if you are eligible to participate. We'll then book you in for an initial appointment at our clinic here in Newstead.
Most of this study can be conducted by home, however, we will ask you to attend our clinic at the start and end of the 12 week study period for a blood test and some basic health assessments. You will also need to attend i-Med radiology clinic at Fortitude Valley for an ultrasound on your Femoral Artery in your thigh at the beginning and end of your participantion.
You'll receive monthly questionnaires to complete, so please make sure to keep an eye out for any emails from us as sometimes they can get lost in junk mail.

The study is a randomised double-blind placebo-controlled study. In this particular study we are testing two different doses of Testofen compared to a placebo.
You will be placed in one of three groups:
Group 1 (active): 300mg Testofen – 2 capsules taken once daily for the duration of the study
Group 2 (active): 600mg Testofen – 2 capsules taken once daily for the duration of the study
Group 3 (placebo): Maltodextrin – 2 capsules taken once daily for the duration of the study


For the duration of the study, you will be required to take your study product each day and the dosage is 2 capsules each morning.

Once you have completed the study, you will be paid $150 as a thank you for your time and effort and to cover any out of pocket expenses.

Do you have any questions about the study process?

Participant still interested after study summary?*

Screening Questions

Are you aged between 40 and 75?
Not Eligible
Needs to be 35 or under
Not Eligible
Are you currently in a sexual relationship?
Not Eligible
Do you agree not to change current diet or exercise regime during the study period?
Not Eligible
Have you participated in any other trials in the last month?
Not Eligible
Do you agree not to start any other clinical trials whilst enrolled in this study?
Not Eligible
Do you currently suffer from any unstable or serious illnesses? (eg. serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, hormone production disorder*)
*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, diabetes (even if controlled)
Not Eligible
Any medications or supplements that you take or use regularly?
Exclusion criteria - Blood thinners/Anticoagulation therapies (Warfarin, heparin, dalteparin, enoxaparin) or other anticoagulation therapy (eg thromboembolectomy or the use of vena cava filters.
Any treatments for Erectile Dysfunction, for example - Sildenafil (Viagra), vardenafil (Levitra, Staxyn), tadalafil (Cialis) and avanafil (Stendra). Treatments for diabetes - eg insulin or metformin
Please list any medications below
Name
Dose
Frequency
Reason
Prescribed? (Y/N)
 
Do you have a history of prostate surgery and/or trauma?
Not Eligible
Are you using any treatments to increase or decrease nitrate or nitric oxide levels?
Not Eligible
Have you had or been treated for cancer in the past 2 years?
Not Eligible
Are you currently using any treatments for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories?
Not Eligible
Are you currently using any treatments to increase or decrease your testosterone levels?
eg. androgens/antiandrogens
Not Eligible
Do you smoke/use e-cigarettes or recreational drugs?
Not Eligible
Do you regularly drink more than 14 standard alcoholic drinks a week (or have you in the past)?
Not Eligible
Any allergies to any drugs, supplements or foods?
Exclude any allergies to the active or placebo ingredients
Screening Result?
Have you informed the participant that we have other studies recruiting that they may be eligible for?
Did the participant seem interested in any other studies?
If person fails screening or is not interested, please just type xxxx. Do NOT put the actual participant ID in this field unless they have PASSED screening.

Participant Details

Are you currently working?

Do you have a partner?
Do you have children living at home with you?
Do you exercise regularly?
Next we will email you out a digital consent form for you to read and sign online.

Once we have received your consent back, we will then email you the screening Erectile Function Questionnaire. Once we've confirmed your eligibility, we'll contact you to book in your initial appointment with us at the clinic and organise a time for you to have your baseline femoral artery scan.

Do you have any other questions?

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