Effect of Testofen on Erectile Function in an Adult Male Population

NCT05232279 | Recruiting Phase 3

• 1 other identifier: TESTEF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Change in the Ageing Male Symptom (AMS) Questionnaire

  Baseline prior to commencement of study product and Week 12

• Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)

  Baseline prior to commencement of study product and Week 12

• Change in cardiovascular health

  Baseline prior to commencement of study product and Week 12

• Change in cardiovascular circulation

  Baseline prior to commencement of study product and Week 12

• Change in height in anthropometry measurements

  Baseline prior to commencement of study product and Week 12

Study Arms (3)

Testofen 300mg

EXPERIMENTAL

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

Drug: Testofen 300mg

Testofen 600mg

EXPERIMENTAL

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

Drug: Testofen 600mg

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

Interventions

Testofen 300mg DRUG

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

Testofen 300mg

Testofen 600mg DRUG

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

Testofen 600mg

Placebo comparator DRUG

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.

Placebo comparator

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Amanda Rao, PhD

  RDC Clinical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Rao, PhD

CONTACT

+61 414 488 559; amanda@rdcglobal.com.au

David Briskey, PhD

CONTACT

+61 421 784 077; david@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 9, 2022
• Study Start: April 19, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)