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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
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.
RDC Clinical Pty Ltd
Brisbane, Queensland, Australia
RECRUITINGChange 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 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.
Time frame: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
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 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.
Time frame: Baseline prior to commencement of study product and Week 12
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 12
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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 12
Change in height in anthropometry measurements
Height as measured by stadiometer in centimeters
Time frame: Baseline prior to commencement of study product and Week 12
Change in weight in anthropometry measurements
Weight as measured by digital scales in kilograms
Time frame: 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
Time frame: Baseline prior to commencement of study product and Week 12