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Erectile DysfunctionPhase 3NCT05232279

Effect of Testofen on Erectile Function in an Adult Male Population

A Phase 3 study testing Testofen 300mg and Testofen 600mg in people with Erectile Dysfunction, run by RDC Clinical Pty Ltd at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Testofen 300mg and Testofen 600mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteAustralia
Study dates
19 Apr 2022to 22 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • RDC Clinical Pty Ltd

    Brisbane, Queensland, 4006

Other trials in Australia

About this study

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

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.

Being tested
Testofen 300mg, Testofen 600mg, Placebo comparator
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05232279
Study groupRoleWhat they receive
Testofen 300mgExperimentalTestofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Receives: Drug: Testofen 300mg
Testofen 600mgExperimentalTestofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
Receives: Drug: Testofen 600mg
Placebo comparatorPlacebo comparatorThe 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.
Receives: Drug: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12

  2. 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.

    Measured: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12

Secondary outcomes (27)

  1. 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.

    Measured: Baseline prior to commencement of study product and Week 12

  2. 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.

    Measured: Baseline prior to commencement of study product and Week 12

  3. Change in cardiovascular health

    Blood pressure (BP) as measured by automatic blood pressure machine

    Measured: Baseline prior to commencement of study product and Week 12

  4. Change in cardiovascular circulation

    Doppler flow cytometry of the Femoral artery to assess circulation

    Measured: Baseline prior to commencement of study product and Week 12

  5. Change in height in anthropometry measurements

    Height as measured by stadiometer in centimeters

    Measured: Baseline prior to commencement of study product and Week 12

  6. Change in weight in anthropometry measurements

    Weight as measured by digital scales in kilograms

    Measured: Baseline prior to commencement of study product and Week 12

  7. Change in waist circumference in anthropometry measurements

    Waist circumference as measured by tape in centimeters

    Measured: Baseline prior to commencement of study product and Week 12

  8. Hormone levels: Testosterone

    Testosterone hormone levels

    Measured: baseline to week 12

  9. Hormone levels: Free Testosterone

    Free Testosterone hormone levels

    Measured: baseline to week 12

  10. Hormone levels: DHEA-S

    DHEA-S hormone levels

    Measured: baseline to week 12

  11. Hormone levels: androstenedione

    androstenedione hormone levels

    Measured: baseline to week 12

  12. Hormone levels: luteinizing hormone (LH)

    Luteinizing hormone (LH) hormone levels

    Measured: baseline to week 12

  13. Hormone levels: sex hormone binding globulin (SHBG)

    SHBG hormone levels

    Measured: baseline to week 12

  14. Hormone levels: oestrogen

    oestrogen hormone levels

    Measured: baseline to week 12

  15. Hormone levels: 5-Dihydrotestosterone

    5-Dihydrotestosterone hormone levels

    Measured: baseline to week 12

  16. Hormone levels: 5-alpha reductase

    5-alpha reductase hormone levels

    Measured: baseline to week 12

  17. General Safety Markers: Full Blood Count (FBC)

    General Safety Markers: Full Blood Count (FBC)

    Measured: baseline to week 12

  18. General Safety Markers: HgbA1c

    General Safety Markers: HgbA1c

    Measured: baseline to week 12

  19. General Safety Markers: electrolytes

    General Safety Markers: electrolytes via Comprehensive Metabolic Panel (CMP).

    Measured: baseline to week 12

  20. General Safety Markers: renal function

    General Safety Markers: renal function via Comprehensive Metabolic Panel (CMP).

    Measured: baseline to week 12

  21. General Safety Markers: liver function

    General Safety Markers: liver function via Comprehensive Metabolic Panel (CMP).

    Measured: baseline to week 12

  22. General Safety Markers: Lipid profile

    General Safety Markers: lipid profile

    Measured: baseline to week 12

  23. General Safety Markers: TSH

    General Safety Markers: Thyroid-Stimulating Hormone (TSH)

    Measured: baseline to week 12

  24. General Safety Markers: Prolactin

    General Safety Markers: Prolactin

    Measured: baseline to week 12

  25. General Safety Markers: PSA - Insulin

    General Safety Markers: PSA - Insulin

    Measured: baseline to week 12

  26. Participant experience

    Participant experience will be via a study exit form

    Measured: week 12

  27. Safety: Undesirable and unwanted events

    Participants will be contacted by phone on weeks 4 and 8 to see how they are going and assess for any adverse events. Additionally, participants are advised to contact the clinic throughout the trial if an adverse event is experienced.

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start19 Apr 2022
  3. Primary completion22 Jul 2026
  4. Study completion22 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05232279
Sponsor's protocol ID
TESTEF
Status last verified
Jul 2026
First submitted
18 Jan 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD information will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Testofen 300mg and Testofen 600mg in people with Erectile Dysfunction, run by RDC Clinical Pty Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Index of Erectile Function (IIEF) questionnaire (time frame: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05232279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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