Effect of Testofen on Erectile Function in an Adult Male Population

July 23, 2026 updated by: RDC Clinical Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • RDC Clinical Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Testofen 300mg
Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Drug: Testofen 300mg
Testofen in capsule form - To be 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.
Drug: Testofen 600mg
Testofen in capsule form - To be 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Change in Erection Hardness Score (EHS)
Time Frame: Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Ageing Male Symptom (AMS) Questionnaire
Time Frame: Baseline prior to commencement of study product and Week 12
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
Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)
Time Frame: Baseline prior to commencement of study product and Week 12
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
Change in cardiovascular health
Time Frame: Baseline prior to commencement of study product and Week 12
Blood pressure (BP) as measured by automatic blood pressure machine
Baseline prior to commencement of study product and Week 12
Change in cardiovascular circulation
Time Frame: Baseline prior to commencement of study product and Week 12
Doppler flow cytometry of the Femoral artery to assess circulation
Baseline prior to commencement of study product and Week 12
Change in height in anthropometry measurements
Time Frame: Baseline prior to commencement of study product and Week 12
Height as measured by stadiometer in centimeters
Baseline prior to commencement of study product and Week 12
Change in weight in anthropometry measurements
Time Frame: Baseline prior to commencement of study product and Week 12
Weight as measured by digital scales in kilograms
Baseline prior to commencement of study product and Week 12
Change in waist circumference in anthropometry measurements
Time Frame: Baseline prior to commencement of study product and Week 12
Waist circumference as measured by tape in centimeters
Baseline prior to commencement of study product and Week 12
Hormone levels: Testosterone
Time Frame: baseline to week 12
Testosterone hormone levels
baseline to week 12
Hormone levels: Free Testosterone
Time Frame: baseline to week 12
Free Testosterone hormone levels
baseline to week 12
Hormone levels: DHEA-S
Time Frame: baseline to week 12
DHEA-S hormone levels
baseline to week 12
Hormone levels: androstenedione
Time Frame: baseline to week 12
androstenedione hormone levels
baseline to week 12
Hormone levels: luteinizing hormone (LH)
Time Frame: baseline to week 12
Luteinizing hormone (LH) hormone levels
baseline to week 12
Hormone levels: sex hormone binding globulin (SHBG)
Time Frame: baseline to week 12
SHBG hormone levels
baseline to week 12
Hormone levels: oestrogen
Time Frame: baseline to week 12
oestrogen hormone levels
baseline to week 12
Hormone levels: 5-Dihydrotestosterone
Time Frame: baseline to week 12
5-Dihydrotestosterone hormone levels
baseline to week 12
Hormone levels: 5-alpha reductase
Time Frame: baseline to week 12
5-alpha reductase hormone levels
baseline to week 12
General Safety Markers: Full Blood Count (FBC)
Time Frame: baseline to week 12
General Safety Markers: Full Blood Count (FBC)
baseline to week 12
General Safety Markers: HgbA1c
Time Frame: baseline to week 12
General Safety Markers: HgbA1c
baseline to week 12
General Safety Markers: electrolytes
Time Frame: baseline to week 12
General Safety Markers: electrolytes via Comprehensive Metabolic Panel (CMP).
baseline to week 12
General Safety Markers: renal function
Time Frame: baseline to week 12
General Safety Markers: renal function via Comprehensive Metabolic Panel (CMP).
baseline to week 12
General Safety Markers: liver function
Time Frame: baseline to week 12
General Safety Markers: liver function via Comprehensive Metabolic Panel (CMP).
baseline to week 12
General Safety Markers: Lipid profile
Time Frame: baseline to week 12
General Safety Markers: lipid profile
baseline to week 12
General Safety Markers: TSH
Time Frame: baseline to week 12
General Safety Markers: Thyroid-Stimulating Hormone (TSH)
baseline to week 12
General Safety Markers: Prolactin
Time Frame: baseline to week 12
General Safety Markers: Prolactin
baseline to week 12
General Safety Markers: PSA - Insulin
Time Frame: baseline to week 12
General Safety Markers: PSA - Insulin
baseline to week 12
Participant experience
Time Frame: week 12
Participant experience will be via a study exit form
week 12
Safety: Undesirable and unwanted events
Time Frame: Baseline to week 12
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.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RDC Clinical Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmako Biotechnologies Pty Ltd
Gencor Pacific Limited, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda Rao, PhD, RDC Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TESTEF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD information will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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