TestosteroneNCT07028255
Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels
A study testing Qualia Testosterone in people with Testosterone, run by Qualia Life Sciences at 1 site in United States.
Trial summary
This is a 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. Read more about this study
- Who is it for?
- Ages 28 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testosterone
- What is being tested?
- Qualia Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2025to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels: A Double-Blind Parallel Trial
This is a 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 assigned 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.
Read the detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
- Conditions
- Testosterone
- Being tested
- Qualia Testosterone, Placebo
- Keywords
- testosterone supplementation, testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia TestosteroneDietary supplement
Qualia Testosterone manufactured by Qualia Life Sciences
PlaceboDietary supplement
Rice Flour
| Study group | Role | What they receive |
|---|---|---|
| Qualia Testosterone | Active comparator | Qualia Testosterone manufactured by Qualia Life Sciences Receives: Dietary Supplement: Qualia Testosterone |
| Placebo | Placebo comparator | Rice Flour Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
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
Measured: Week 3
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
Measured: Week 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start13 Jul 2025
- Primary completion18 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TestosteroneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028255
- Sponsor's protocol ID
- QLS-013
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels: A Double-Blind Parallel Trial
- ClinicalTrials.gov ID
- NCT07028255
- Acronym / sponsor ID
- QLS-013
- Conditions
- Testosterone
- Keywords
- testosterone supplementation, testosterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 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 assigned 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.
Detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualia Testosterone | Active comparator | Dietary Supplement: Qualia TestosteroneQualia Testosterone manufactured by Qualia Life Sciences |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboRice Flour |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia TestosteroneQualia Testosterone manufactured by Qualia Life Sciences | Dietary supplement | Qualia Testosterone |
| PlaceboRice Flour | Dietary supplement | Placebo |
Primary outcome
Between-group change in blood testosterone levels
Time frame: 3 weeks
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.
2 secondary outcomes
Aging Male Symptoms Scale scores
Time frame: Week 3
Side effect profile as measured by a custom Safety and Tolerability survey
Time frame: Week 1, 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Testosterone in people with Testosterone, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group change in blood testosterone levels (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.