Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
19/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
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
amanda@rdcglobal.com.au
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