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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testofen 300mg | Experimental | Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks. |
|
| Testofen 600mg | Experimental | Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks. |
|
| Placebo comparator | Placebo 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testofen 300mg | Drug | Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 |
| 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. | Baseline prior to commencement of study product, Week 4, Week 8 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline prior to commencement of study product and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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.](streamdown:incomplete-link)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rao, PhD | Contact | +61 414 488 559 | amanda@rdcglobal.com.au | |
| David Briskey, PhD | Contact | +61 421 784 077 | david@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Recruiting | Brisbane | Queensland | 4006 | Australia |
No IPD information will be shared
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Testofen 600mg | Drug | Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks. |
|
| Placebo comparator | Drug | 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. |
|
| 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. | Baseline prior to commencement of study product and Week 12 |
| Change in cardiovascular health | Blood pressure (BP) as measured by automatic blood pressure machine | Baseline prior to commencement of study product and Week 12 |
| Change in cardiovascular circulation | Doppler flow cytometry of the Femoral artery to assess circulation | Baseline prior to commencement of study product and Week 12 |
| Change in height in anthropometry measurements | Height as measured by stadiometer in centimeters | Baseline prior to commencement of study product and Week 12 |
| Change in weight in anthropometry measurements | Weight as measured by digital scales in kilograms | Baseline prior to commencement of study product and Week 12 |
| Change in waist circumference in anthropometry measurements | Waist circumference as measured by tape in centimeters | Baseline prior to commencement of study product and Week 12 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |