Actively Recruiting

Phase 3
Age: 40Years - 75Years
MALE
NCT05232279

Effect of Testofen on Erectile Function in an Adult Male Population

Led by RDC Clinical Pty Ltd · Updated on 2025-07-24

120

Participants Needed

1

Research Sites

214 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of Testofen on Erectile Function in an Adult Male Population

Who Can Participate

Age: 40Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male adults aged 40-75 years
  • Currently in a sexual relationship
  • Reduced erectile function with an International Index of Erectile Function (IIEF) score less than 25
  • Body Mass Index (BMI) of 35 or less
  • Able to provide informed consent
  • Agree to maintain current diet and exercise program during the study
  • Agree not to participate in another clinical trial during the study
Not Eligible

You will not qualify if you...

  • History of prostate surgery and/or trauma
  • Receiving or prescribed treatment for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories
  • Receiving or prescribed treatment to increase or decrease testosterone levels (e.g., androgens or anti-androgens)
  • Receiving or prescribed treatment to alter nitrate or nitric oxide levels
  • Having unstable or serious illnesses such as serious mood disorders, neurological disorders (e.g., MS), kidney disease, liver disease, heart conditions, diabetes, or hormone production disorders
  • Current malignancies (excluding basal cell carcinoma) or recent chemotherapy/radiotherapy within the past 2 years
  • Receiving anticoagulation therapy such as warfarin, heparin, or related treatments
  • Active smokers, nicotine users, or persons with alcohol or drug abuse
  • Chronic alcohol use exceeding 14 alcoholic drinks per week
  • Allergic to any ingredients in the active or placebo capsules
  • Any condition that the investigator deems makes participation unsuitable
  • Participation in another related clinical study within the past month
  • Participants told by their doctor they have hormone production disorders such as under or overproduction of hormones (e.g., testosterone)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RDC Clinical Pty Ltd

Brisbane, Queensland, Australia, 4006

Actively Recruiting

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Research Team

A

Amanda Rao, PhD

CONTACT

D

David Briskey, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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