Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
RDC Clinical Pty Ltd
RECRUITING
Brisbane
Contact Information
Primary
Amanda Rao, PhD
amanda@rdcglobal.com.au
+61 414 488 559
Backup
David Briskey, PhD
david@rdcglobal.com.au
+61 421 784 077
Time Frame
Start Date: 2022-04-19
Estimated Completion Date: 2026-06
Participants
Target number of participants: 120
Treatments
Experimental: Testofen 300mg
Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.
Experimental: Testofen 600mg
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.
Related Therapeutic Areas
Sponsors
Leads: RDC Clinical Pty Ltd