Erectile Dysfunction
Conditions
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.
Interventions
DRUGTestofen 300mg
Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
DRUGTestofen 600mg
Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.
DRUGPlacebo comparator
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.
Sponsors
RDC Clinical Pty Ltd
Pharmako Biotechnologies Pty Ltd
Gencor Pacific Limited, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Index of Erectile Function (IIEF) questionnaire | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 | 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) | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Ageing Male Symptom (AMS) Questionnaire | Baseline prior to commencement of study product and Week 12 | 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) | Baseline prior to commencement of study product and Week 12 | 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 | Baseline prior to commencement of study product and Week 12 | Blood pressure (BP) as measured by automatic blood pressure machine |
| Change in cardiovascular circulation | Baseline prior to commencement of study product and Week 12 | Doppler flow cytometry of the Femoral artery to assess circulation |
| Change in height in anthropometry measurements | Baseline prior to commencement of study product and Week 12 | Height as measured by stadiometer in centimeters |
| Change in weight in anthropometry measurements | Baseline prior to commencement of study product and Week 12 | Weight as measured by digital scales in kilograms |
| Change in waist circumference in anthropometry measurements | Baseline prior to commencement of study product and Week 12 | Waist circumference as measured by tape in centimeters |
| Hormone levels: Testosterone | baseline to week 12 | Testosterone hormone levels |
| Hormone levels: Free Testosterone | baseline to week 12 | Free Testosterone hormone levels |
| Hormone levels: DHEA-S | baseline to week 12 | DHEA-S hormone levels |
| Hormone levels: androstenedione | baseline to week 12 | androstenedione hormone levels |
| Hormone levels: luteinizing hormone (LH) | baseline to week 12 | Luteinizing hormone (LH) hormone levels |
| Hormone levels: sex hormone binding globulin (SHBG) | baseline to week 12 | SHBG hormone levels |
| Hormone levels: oestrogen | baseline to week 12 | oestrogen hormone levels |
| Hormone levels: 5-Dihydrotestosterone | baseline to week 12 | 5-Dihydrotestosterone hormone levels |
| Hormone levels: 5-alpha reductase | baseline to week 12 | 5-alpha reductase hormone levels |
| General Safety Markers: Full Blood Count (FBC) | baseline to week 12 | General Safety Markers: Full Blood Count (FBC) |
| General Safety Markers: HgbA1c | baseline to week 12 | General Safety Markers: HgbA1c |
| General Safety Markers: electrolytes | baseline to week 12 | General Safety Markers: electrolytes via Comprehensive Metabolic Panel (CMP). |
| General Safety Markers: renal function | baseline to week 12 | General Safety Markers: renal function via Comprehensive Metabolic Panel (CMP). |
| General Safety Markers: liver function | baseline to week 12 | General Safety Markers: liver function via Comprehensive Metabolic Panel (CMP). |
| General Safety Markers: Lipid profile | baseline to week 12 | General Safety Markers: lipid profile |
| General Safety Markers: TSH | baseline to week 12 | General Safety Markers: Thyroid-Stimulating Hormone (TSH) |
| General Safety Markers: Prolactin | baseline to week 12 | General Safety Markers: Prolactin |
| General Safety Markers: PSA - Insulin | baseline to week 12 | General Safety Markers: PSA - Insulin |
| Participant experience | week 12 | Participant experience will be via a study exit form |
| Safety: Undesirable and unwanted events | Baseline to week 12 | Participants will be contacted by phone on weeks 4 and 8 to see how they are going and assess for any adverse events. Additionally, participants are advised to contact the clinic throughout the trial if an adverse event is experienced. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORAmanda Rao, PhD
RDC Clinical
Outcome results
None listed