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Recruiting Phase 3 NCT05232279

Effect of Testofen on Erectile Function in an Adult Male Population

Phase 3 – large-scale trial before approval
Conditions: Erectile Dysfunction

Sponsor: RDC Clinical Pty Ltd

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 1
Australia (1)
RDC Clinical Pty Ltd
Brisbane , Queensland
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
40 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
19.04.2022
Completion date
01.06.2026
Registry ID
NCT05232279
Source
anzctr
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