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

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