Clinical trial NCT05232279: Effect of Testofen on Erectile Function in an Adult Male Population
Official title: Effect of Testofen on Erectile Function in an Adult Male Population - a Double Blind, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Change in International Index of Erectile Function (IIEF) questionnaire
timeFrame: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
measure: Change in Erection Hardness Score (EHS)
timeFrame: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Secondary outcomes:
measure: Change in the Ageing Male Symptom (AMS) Questionnaire
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in cardiovascular health
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in cardiovascular circulation
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in height in anthropometry measurements
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in weight in anthropometry measurements
timeFrame: Baseline prior to commencement of study product and Week 12
measure: Change in waist circumference in anthropometry measurements
timeFrame: Baseline prior to commencement of study product and Week 12
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: