Testofen 300mg: Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Testofen 600mg: Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
Placebo comparator: 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.
Study summary
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
Sex
MALE
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in International Index of Erectile Function (IIEF) questionnaire — Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 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
Change in Erection Hardness Score (EHS) — Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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