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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05232279




Registration number
NCT05232279
Ethics application status
Date submitted
18/01/2022
Date registered
9/02/2022

Titles & IDs
Public title
Effect of Testofen on Erectile Function in an Adult Male Population
Scientific title
Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.
Secondary ID [1] 0 0
TESTEF
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testofen 300mg
Treatment: Drugs - Testofen 600mg
Treatment: Drugs - Placebo comparator

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

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

Placebo comparator: 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.


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

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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in International Index of Erectile Function (IIEF) questionnaire
Timepoint [1] 0 0
Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Primary outcome [2] 0 0
Change in Erection Hardness Score (EHS)
Timepoint [2] 0 0
Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Secondary outcome [1] 0 0
Change in the Ageing Male Symptom (AMS) Questionnaire
Timepoint [1] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [2] 0 0
Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)
Timepoint [2] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [3] 0 0
Change in cardiovascular health
Timepoint [3] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [4] 0 0
Change in cardiovascular circulation
Timepoint [4] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [5] 0 0
Change in height in anthropometry measurements
Timepoint [5] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [6] 0 0
Change in weight in anthropometry measurements
Timepoint [6] 0 0
Baseline prior to commencement of study product and Week 12
Secondary outcome [7] 0 0
Change in waist circumference in anthropometry measurements
Timepoint [7] 0 0
Baseline prior to commencement of study product and Week 12

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD information will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05232279