Effect of Testofen on Erectile Function in an Adult Male Population
ConditionErectile Dysfunction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age40-75
SponsorRDC Clinical Pty Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
Healthy male adults aged 40-75 years
Currently in a sexual relationship
Males with reduced erectile function (Score of <25 on IIEF)
BMI ≤ 35
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Testofen 300mg
DrugTestofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Testofen 600mg
DrugTestofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
Placebo comparator
DrugThe 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Testofen 300mgExperimental treatment 1 intervention
Group B: Testofen 600mgExperimental treatment 1 intervention
Group C: Placebo comparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline prior to commencement of study product, Week 4, Week 8 and Week 122
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.
Time frame
Baseline prior to commencement of study product, Week 4, Week 8 and Week 12Secondary outcomes
1
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.
Time frame
Baseline prior to commencement of study product and Week 122
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.
Time frame
Baseline prior to commencement of study product and Week 123
Change in cardiovascular health
Blood pressure (BP) as measured by automatic blood pressure machine
Time frame
Baseline prior to commencement of study product and Week 124
Change in cardiovascular circulation
Doppler flow cytometry of the Femoral artery to assess circulation
Time frame
Baseline prior to commencement of study product and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov