Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels
ConditionTestosterone
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age28-65
SponsorQualia Life Sciences
About this trial
This is a randomized, double-blind, placebo-controlled parallel trial designed to assess the efficacy of Qualia Testosterone, a novel dietary supplement, in adult males aged 28 to 65 experiencing symptoms associated with testosterone deficiency. Approximately 60 participants will be randomized to receive either Qualia Testosterone (2 capsules daily) or a matched placebo for 21 days, with dosing administered each morning. The study's primary outcomes are changes in total testosterone, free testosterone (via dialysis), and dihydrotestosterone levels from baseline to Week 3. Secondary outcomes include changes in Aging Male Symptoms Scale scores-encompassing psychological, somatic, and sexual domains-as well as safety and tolerability. Blood samples will be collected in a laboratory setting, while symptom and safety assessments will be completed electronically at home.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Qualia Testosterone
Dietary supplementQualia Testosterone manufactured by Qualia Life Sciences
Placebo
Dietary supplementRice Flour
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Qualia TestosteroneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-group change in blood testosterone levels
To assess the between-group differences in change from baseline to Week 3 in Total Testosterone, Free (Dialysis) Testosterone, and Dihydrotestosterone levels following Qualia Testosterone supplementation.
Time frame
3 weeksSecondary outcomes
1
Aging Male Symptoms Scale scores
To evaluate between-group changes in Overall, Psychological, Somatic, and Sexual scores on the Aging Male Symptoms Scale from baseline to Week 3
Time frame
Week 32
Side effect profile as measured by a custom Safety and Tolerability survey
Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey
Time frame
Week 1, 2 and 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: