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New treatment option for Erectile Dysfunction
Official title Effect of Testofen on Erectile Function in an Adult Male Population
ClinicalTrials.gov ID: NCT05232279
What this study is testing
What is Testofen 300mg?
Testofen 300mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for erectile dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75, men only
You may be able to join 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
You likely can't join if
- History of prostate surgery and/or trauma
- Receiving/prescribed treatment for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections, or urethral...
- 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...
- All current malignancies (excluding BCC) or chemotherapy and/or radiotherapy treatment for malignancy within the previous 2 years
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.