Back to resultsEffect of Testofen on Erectile Function in an Adult Male Population
Primary Purpose
Erectile Dysfunction
Status
Recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Testofen 300mg
Testofen 600mg
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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.
Sites / Locations
- RDC Clinical Pty LtdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Testofen 300mg
Testofen 600mg
Placebo comparator
Arm Description
Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
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.
Outcomes
Primary Outcome Measures
Change in International Index of Erectile Function (IIEF) questionnaire
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
Change in Erection Hardness Score (EHS)
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 Outcome Measures
Change in the Ageing Male Symptom (AMS) Questionnaire
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.
Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)
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.
Change in cardiovascular health
Blood pressure (BP) as measured by automatic blood pressure machine
Change in cardiovascular circulation
Doppler flow cytometry of the Femoral artery to assess circulation
Change in height in anthropometry measurements
Height as measured by stadiometer in centimeters
Change in weight in anthropometry measurements
Weight as measured by digital scales in kilograms
Change in waist circumference in anthropometry measurements
Waist circumference as measured by tape in centimeters
Full Information
NCT ID
NCT05232279
First Posted
January 18, 2022
Last Updated
October 22, 2023
Sponsor
RDC Clinical Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05232279
Brief Title
Effect of Testofen on Erectile Function in an Adult Male Population
Official Title
Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDC Clinical Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Testofen 300mg
Arm Type
Experimental
Arm Description
Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Arm Title
Testofen 600mg
Arm Type
Experimental
Arm Description
Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Testofen 300mg
Intervention Description
Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Testofen 600mg
Intervention Description
Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention 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.
Primary Outcome Measure Information:
Title
Change in International Index of Erectile Function (IIEF) questionnaire
Description
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
Time Frame
Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Title
Change in Erection Hardness Score (EHS)
Description
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.
Time Frame
Baseline prior to commencement of study product, Week 4, Week 8 and Week 12
Secondary Outcome Measure Information:
Title
Change in the Ageing Male Symptom (AMS) Questionnaire
Description
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.
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)
Description
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.
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in cardiovascular health
Description
Blood pressure (BP) as measured by automatic blood pressure machine
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in cardiovascular circulation
Description
Doppler flow cytometry of the Femoral artery to assess circulation
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in height in anthropometry measurements
Description
Height as measured by stadiometer in centimeters
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in weight in anthropometry measurements
Description
Weight as measured by digital scales in kilograms
Time Frame
Baseline prior to commencement of study product and Week 12
Title
Change in waist circumference in anthropometry measurements
Description
Waist circumference as measured by tape in centimeters
Time Frame
Baseline prior to commencement of study product and Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name or Official Title & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Organizational Affiliation
RDC Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
RDC Clinical Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD information will be shared
Learn more about this trial
Effect of Testofen on Erectile Function in an Adult Male Population
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