Sexual FunctionNCT06596928
A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
A study testing Essential Elements T-Hero Platinum in people with Sexual Function and Cognitive Functions, run by Scale Media Inc at 1 site in United States.
Trial summary
This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Function, Cognitive Functions, Testosterone
- What is being tested?
- Essential Elements T-Hero Platinum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 1 Sep 2024
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male (biological at birth).
- Aged between 30-65.
- Generally healthy - do not live with any uncontrolled chronic disease such as diabetes or hypertension.
- Willing to provide blood draws during the study duration.
- Fitness/wellness enthusiast who has the same weekly exercise routine i.e. HIIT, strength training, or running \>3 times per week.
- Self-reported concerns with energy levels, mood, and libido and sexual performance/adequacy.
- Willing to avoid medications, supplements, or vitamins aimed at increasing testosterone levels for the duration of the study.
Who cannot join
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions requiring the use of an Epi-Pen.
- Unwilling to follow the study protocol.
- Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder).
- Current substance abuse disorder.
- Any medical condition that is unstable or uncontrolled.
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- Has introduced any new prescription medication or supplements within the past 12 weeks that influence testosterone production.
- History of testicular or prostate cancer.
- Previously has undergone a vasectomy.
- Currently undergoing hormone replacement therapy (HRT)
- Currently taking performance-enhancing drugs.
- Anyone taking prescription blood pressure, immunosuppressants, sleeping aids, anti-seizure, and/or thyroid medications.
- Living in New York, Rhode Island, Hawaii, or Alaska.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.
- Conditions
- Sexual Function, Cognitive Functions, Testosterone
- Being tested
- Essential Elements T-Hero Platinum, Placebo
- Keywords
- Mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Elements T-Hero PlatinumDietary supplement
Participants will take two capsules daily for 90 days
PlaceboDietary supplement
Participants in the placebo group will take two placebo capsules daily for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Test Supplement Group | Experimental | Participants in this group will receive the test supplement (Essential Elements T-Hero Platinum). The supplement contains ingredients aimed at supporting testosterone levels, including Shoden® Ashwagandha Root and Leaf Extract. Receives: Dietary Supplement: Essential Elements T-Hero Platinum |
| Placebo Group | Placebo comparator | Participants in this group will receive a placebo containing rice flour in a vegetable cellulose capsule. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Free and Total Testosterone Levels
This study will measure the changes in free and total testosterone levels in male participants. Blood samples will be collected at Baseline, Day 45, and Day 90. The primary goal is to assess the effectiveness of the test supplement in increasing testosterone levels compared to the placebo group.
Measured: Baseline, Day 45, Day 90
Secondary outcomes (1)
Change in Cognitive Function, Mood, Energy, and Sexual Function
This study will assess self-reported changes in cognitive function, mood, energy levels, and sexual function. Participants will complete validated questionnaires, including the Profile of Mood States (POMS) questionnaire, at Baseline, Day 45, and Day 90. The goal is to evaluate improvements in these parameters and their correlation with increased testosterone levels.
Measured: Baseline, Day 45, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 May 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual FunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scale Media Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596928
- Sponsor's protocol ID
- 20430
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
- ClinicalTrials.gov ID
- NCT06596928
- Acronym / sponsor ID
- 20430
- Conditions
- Sexual Function, Cognitive Functions, Testosterone
- Keywords
- Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Scale Media IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (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 randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Supplement Group | Experimental | Dietary Supplement: Essential Elements T-Hero PlatinumParticipants in this group will receive the test supplement (Essential Elements T-Hero Platinum). The supplement contains ingredients aimed at supporting testosterone levels, including Shoden® Ashwagandha Root and Leaf Extract. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will receive a placebo containing rice flour in a vegetable cellulose capsule. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male (biological at birth).
- Aged between 30-65.
- Generally healthy - do not live with any uncontrolled chronic disease such as diabetes or hypertension.
- Willing to provide blood draws during the study duration.
- Fitness/wellness enthusiast who has the same weekly exercise routine i.e. HIIT, strength training, or running \>3 times per week.
Key exclusion criteria (13 listed)
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions requiring the use of an Epi-Pen.
- Unwilling to follow the study protocol.
- Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder).
- Current substance abuse disorder.
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 |
|---|---|---|
| Essential Elements T-Hero PlatinumParticipants will take two capsules daily for 90 days | Dietary supplement | Test Supplement Group |
| PlaceboParticipants in the placebo group will take two placebo capsules daily for 90 days. | Dietary supplement | Placebo Group |
Primary outcome
Change in Free and Total Testosterone Levels
Time frame: Baseline, Day 45, Day 90
This study will measure the changes in free and total testosterone levels in male participants. Blood samples will be collected at Baseline, Day 45, and Day 90. The primary goal is to assess the effectiveness of the test supplement in increasing testosterone levels compared to the placebo group.
1 secondary outcome
Change in Cognitive Function, Mood, Energy, and Sexual Function
Time frame: Baseline, Day 45, Day 90
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 19 Sep 2024.
- 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 Essential Elements T-Hero Platinum in people with Sexual Function and Cognitive Functions, run by Scale Media Inc 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 7 inclusion and 13 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 19 Sep 2024. 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?
Change in Free and Total Testosterone Levels (time frame: Baseline, Day 45, Day 90). 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 19 Sep 2024.