LibidoNCT05862519
A Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
A study testing Reset, Stay Ready Fiber and Libido in people with Libido and Intimacy, run by 906 CMVI Holdings at 1 site in United States.
Trial summary
This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Libido, Intimacy, Gastrointestinal Issues
- What is being tested?
- Reset, Stay Ready Fiber and Libido
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 13 Jun 2023
- 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 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male (biological at birth) within the LGBTQIA+ community
- Aged between 18-44
- Generally healthy - don't live with any uncontrolled chronic disease
- Generally active lifestyle or seeking to achieve health improvement
- Sexually active with a partner
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.
- 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
- Diagnosis of an autoimmune disease, such as multiple sclerosis and rheumatoid arthritis
Show all 11Show fewer
- Self-reported or diagnosed high blood pressure or hypotension (BP < 90 over 60)
- Currently, or in the past 6 months, undergoing hormone therapy
- Any medical condition that is unstable or uncontrolled
- A history of sexual trauma or abuse
- Has introduced any new prescription medication or supplements within the past 12 weeks that influence gastrointestinal issues, libido, or testosterone production.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.
- Conditions
- Libido, Intimacy, Gastrointestinal Issues
- Being tested
- Reset, Stay Ready Fiber, Libido, Testosterone supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResetDietary supplement
Also called Pure for Men Reset Supplement
Pure for Men Reset is a Vegan, Proprietary Blend of Toxin Eliminating Cleanser: Cascara Sagrada Bark, Senna Leaf, Psyllium Husk, Licorice Root, and Aloe Vera Gel. Taken on Day 1 to Day 5.
Stay Ready FiberDietary supplement
Also called Pure for Men Stay Ready Fiber Capsules
Stay Ready Fiber is a Vegan, 100% Natural, Proprietary Blend of Digestive Aids: Psyllium Husk, Aloe Vera Extract, Chia Seeds \& Flaxseed. Taken from Day 7 through Day 21.
LibidoDietary supplement
Also called Pure for Men Pump Enhancer
Supplement designed to support endurance and increased arousal. Contains L-Citrulline, L-Arginine and Black Pepper Fruit Extract (Piper Nigrum). Taken from Day 7 through to Day 28.
Testosterone supplementDietary supplement
Also called Pure for Men T-Support
Supplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will begin taking the Reset supplement for 5 days. Then there will be a 2-day break with no products taken (wash out period).
Participants will then begin taking the following 2 supplements: Stay Ready Fiber and libido with a partial overlap of products.
Stay Ready Fiber will be taken from day 7 through 21, three capsules will be taken twice daily in the morning and afternoon.
Libido will be taken from day 7 through 28, 2 capsules will be taken daily, preferably with a meal.
Participants will then begin taking the Testosterone supplement. Testosterone will be taken from day 28 through to 84, 2 capsules will be taken daily, preferably with a meal. Receives: Dietary Supplement: Reset; Dietary Supplement: Stay Ready Fiber; Dietary Supplement: Libido; Dietary Supplement: Testosterone supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.
Measured: 12 weeks
Secondary outcomes (1)
Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks]
Survey-based assessment (0-5 scale) of changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start14 Mar 2023
- Primary completion6 Jun 2023 (estimated)
- Study completion13 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LibidoStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- 906 CMVI Holdings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862519
- Sponsor's protocol ID
- 20287
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
- ClinicalTrials.gov ID
- NCT05862519
- Acronym / sponsor ID
- 20287
- Conditions
- Libido, Intimacy, Gastrointestinal Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- 906 CMVI HoldingsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 6 Jun 2023 (estimated)
- Study completion
- 13 Jun 2023 (estimated)
- First posted
- 17 May 2023 (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 study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Reset, Dietary Supplement: Stay Ready Fiber, Dietary Supplement: Libido, Dietary Supplement: Testosterone supplementParticipants will begin taking the Reset supplement for 5 days. Then there will be a 2-day break with no products taken (wash out period). Participants will then begin taking the following 2 supplements: Stay Ready Fiber and libido with a partial overlap of products. Stay Ready Fiber will be taken from day 7 through 21, three capsules will be taken twice daily in the morning and afternoon. Libido will be taken from day 7 through 28, 2 capsules will be taken daily, preferably with a meal. Participants will then begin taking the Testosterone supplement. Testosterone will be taken from day 28 through to 84, 2 capsules will be taken daily, preferably with a meal. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male (biological at birth) within the LGBTQIA+ community
- Aged between 18-44
- Generally healthy - don't live with any uncontrolled chronic disease
- Generally active lifestyle or seeking to achieve health improvement
- Sexually active with a partner
Key exclusion criteria (11 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.
- 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 |
|---|---|---|
| ResetAlso: Pure for Men Reset SupplementPure for Men Reset is a Vegan, Proprietary Blend of Toxin Eliminating Cleanser: Cascara Sagrada Bark, Senna Leaf, Psyllium Husk, Licorice Root, and Aloe Vera Gel. Taken on Day 1 to Day 5. | Dietary supplement | Intervention Group |
| Stay Ready FiberAlso: Pure for Men Stay Ready Fiber CapsulesStay Ready Fiber is a Vegan, 100% Natural, Proprietary Blend of Digestive Aids: Psyllium Husk, Aloe Vera Extract, Chia Seeds \& Flaxseed. Taken from Day 7 through Day 21. | Dietary supplement | Intervention Group |
| LibidoAlso: Pure for Men Pump EnhancerSupplement designed to support endurance and increased arousal. Contains L-Citrulline, L-Arginine and Black Pepper Fruit Extract (Piper Nigrum). Taken from Day 7 through to Day 28. | Dietary supplement | Intervention Group |
| Testosterone supplementAlso: Pure for Men T-SupportSupplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84. | Dietary supplement | Intervention Group |
Primary outcome
Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
Time frame: 12 weeks
Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.
1 secondary outcome
Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks]
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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 Reset, Stay Ready Fiber and Libido in people with Libido and Intimacy, run by 906 CMVI Holdings 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 May 2023. 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. 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?
Results are not available in the source record.
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?
Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks] (time frame: 12 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 17 May 2023.