Effect of Testofen on Erectile Function in an Adult Male Population

RDC Clinical

Status and phase: Enrolling; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo comparator; Drug: Testofen 300mg; Drug: Testofen 600mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05232279

TESTEF

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Testofen 300mg

Experimental group

Description:

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

Treatment:

Drug: Testofen 300mg

Testofen 600mg

Experimental group

Description:

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

Treatment:

Drug: Testofen 600mg

Placebo comparator

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo comparator