Effect of Testofen on Erectile Function in an Adult Male Population

Erectile Dysfunction Clinical Trial

Official title:

Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232279
• Other study ID #: TESTEF
• Status: Recruiting
• Phase: Phase 3
• Start date: April 20, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Primary	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.	Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Secondary	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.	Baseline prior to commencement of study product and Week 12
Secondary	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.	Baseline prior to commencement of study product and Week 12
Secondary	Change in cardiovascular health	Blood pressure (BP) as measured by automatic blood pressure machine	Baseline prior to commencement of study product and Week 12
Secondary	Change in cardiovascular circulation	Doppler flow cytometry of the Femoral artery to assess circulation	Baseline prior to commencement of study product and Week 12
Secondary	Change in height in anthropometry measurements	Height as measured by stadiometer in centimeters	Baseline prior to commencement of study product and Week 12
Secondary	Change in weight in anthropometry measurements	Weight as measured by digital scales in kilograms	Baseline prior to commencement of study product and Week 12
Secondary	Change in waist circumference in anthropometry measurements	Waist circumference as measured by tape in centimeters	Baseline prior to commencement of study product and Week 12