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Clinical Trials in the USA / NCT07028255
Starting soon Not applicable

Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels

NCT07028255 · tracked via the Priya Life Science USA tracker
Sponsor
Qualia Life Sciences
Phase
Not applicable
Started
2025-07-01
Last updated
2025-06-19

Condition(s) studied

Testosterone

Investigational drug(s) / intervention(s)

Qualia TestosteronePlacebo

Qualia Testosterone: Qualia Testosterone manufactured by Qualia Life Sciences

Placebo: Rice Flour

Study summary

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

Sex
MALE
Min age
28 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion criteria: Provide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text Can read and write English Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly Willing to complete questionnaires, records, and diaries associated with the study. Male participants aged 28-65 A score ≥27 on the Aging Males Symptom Scale Willing and able to visit a local blood draw facility for required blood sample collections Live within 20 miles of a suitable blood draw facility Willing to not consume any supplements containing Testosterone starting about 2 weeks prior to the baseline blood test test continuing through the intervention period. Exclusion criteria: Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent Have Hypogonadism

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qualia Life Sciences Carlsbad California

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07028255 on ClinicalTrials.gov ↗ ← All trials in the USA