Effect of Testofen on Erectile Function in an Adult Male Population

Phase 3Active Not RecruitingNCT05232279

RDC Clinical Pty Ltd120 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Erectile Dysfunction

Interventions

Testofen 300mgDRUG

Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.

Testofen 600mgDRUG

Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.

Placebo comparatorDRUG

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.

Eligibility

Sex: MALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

RDC Clinical Pty Ltd

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

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 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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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