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Active, Not Recruiting

NCT Number: NCT05232279

Effect of Testofen on Erectile Function in an Adult Male Population

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testofen 300mg

Drug

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

Testofen 600mg

Drug

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

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Hormone levels: Testosterone

    Time frame: baseline to week 12

    Testosterone hormone levels

  9. Hormone levels: Free Testosterone

    Time frame: baseline to week 12

    Free Testosterone hormone levels

  10. Hormone levels: DHEA-S

    Time frame: baseline to week 12

    DHEA-S hormone levels

  11. Hormone levels: androstenedione

    Time frame: baseline to week 12

    androstenedione hormone levels

  12. Hormone levels: luteinizing hormone (LH)

    Time frame: baseline to week 12

    Luteinizing hormone (LH) hormone levels

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

    Time frame: baseline to week 12

    SHBG hormone levels

  14. Hormone levels: oestrogen

    Time frame: baseline to week 12

    oestrogen hormone levels

  15. Hormone levels: 5-Dihydrotestosterone

    Time frame: baseline to week 12

    5-Dihydrotestosterone hormone levels

  16. Hormone levels: 5-alpha reductase

    Time frame: baseline to week 12

    5-alpha reductase hormone levels

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

    Time frame: baseline to week 12

    General Safety Markers: Full Blood Count (FBC)

  18. General Safety Markers: HgbA1c

    Time frame: baseline to week 12

    General Safety Markers: HgbA1c

  19. General Safety Markers: electrolytes

    Time frame: baseline to week 12

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

  20. General Safety Markers: renal function

    Time frame: baseline to week 12

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

  21. General Safety Markers: liver function

    Time frame: baseline to week 12

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

  22. General Safety Markers: Lipid profile

    Time frame: baseline to week 12

    General Safety Markers: lipid profile

  23. General Safety Markers: TSH

    Time frame: baseline to week 12

    General Safety Markers: Thyroid-Stimulating Hormone (TSH)

  24. General Safety Markers: Prolactin

    Time frame: baseline to week 12

    General Safety Markers: Prolactin

  25. General Safety Markers: PSA - Insulin

    Time frame: baseline to week 12

    General Safety Markers: PSA - Insulin

  26. Participant experience

    Time frame: week 12

    Participant experience will be via a study exit form

  27. 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.

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong
  • Pharmako Biotechnologies Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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