Effect of Testofen on Erectile Function in an Adult Male Population

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Testofen 300mg
* Drug: Testofen 600mg
* Drug: Placebo comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testofen 300mg<br>Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks. | Drug: Testofen 300mg<br>* Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.<br>|
| Experimental: Testofen 600mg<br>Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks. | Drug: Testofen 600mg<br>* Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.<br>|
| Placebo Comparator: Placebo comparator<br>The placebo will consist of maltodextrin and will appear identical to the Testofen capsules. The placebo will be administered as per the active treatment - 2 capsules once daily for 12 weeks. | Drug: Placebo comparator<br>* The placebo will consist of maltodextrin and will appear identical to the Testofen capsules. The placebo will be administered as per the active treatment - 2 capsules once daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Index of Erectile Function (IIEF) questionnaire | The IIEF is a self-administered questionnaire in which participants will be asked to answer 15 questions relating to erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. Lower scores indicated higher perceived erectile dysfunction | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 | 
| Change in Erection Hardness Score (EHS) | Participants will be required to assess their erection quality by using the EHS. They will be asked to rate the hardness of their erection on a scale of one to four, with four being the maximal score. | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Ageing Male Symptom (AMS) Questionnaire | The Ageing Males' Symptoms scale (AMS) is a self-administered questionnaire that will help assess the symptoms of ageing, often related to androgen decline. As the men in this population are aged between 40 and 75 years, this questionnaire will be used to assess any changes in quality of life. | Baseline prior to commencement of study product and Week 12 | 
| Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR) | The DISF-SR is composed of 25 items and examines different aspects of human sexual functioning including sexual cognition and fantasy, sexual arousal, sexual behaviour and experiences, orgasm, and sexual drive and relationship. | Baseline prior to commencement of study product and Week 12 | 
| Change in cardiovascular health | Blood pressure (BP) as measured by automatic blood pressure machine | Baseline prior to commencement of study product and Week 12 | 
| Change in cardiovascular circulation | Doppler flow cytometry of the Femoral artery to assess circulation | Baseline prior to commencement of study product and Week 12 | 
| Change in height in anthropometry measurements | Height as measured by stadiometer in centimeters | Baseline prior to commencement of study product and Week 12 | 
| Change in weight in anthropometry measurements | Weight as measured by digital scales in kilograms | Baseline prior to commencement of study product and Week 12 | 
| Change in waist circumference in anthropometry measurements | Waist circumference as measured by tape in centimeters | Baseline prior to commencement of study product and Week 12 |