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    What You Need to Know to Participate

    This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.

    Summary Information to Help you Decide Whether to Join this Study

    Study Title MarsMen Testosterone Support 3-Month Evaluation
    Study Author Matthew Amsden
    Sponsor This study is made possible by your payment to join.
    Cost of Products, Services & Information to Participant $0
    Included Products & Services MarsMen Natural Testosterone Support, Men’s Health Blood Test
    Outcome Measures Men’s Health Blood Test, PROMIS Physical Function – Short Form 10a Survey, General Anxiety Disorder (GAD-7)
    Contact help@efforia.com

    Introduction & Summary

    Welcome to the MarsMen Testosterone Support 3-Month Evaluation study on Efforia. Your participation helps make this research possible. This document contains essential information about the study to help you decide if you want to join. The study aims to explore the effects of the MarsMen Natural Testosterone Support supplement. Your participation is voluntary, and you can leave the study at any time without penalty. Please feel free to reach out with any questions you might have before joining.

    Purpose of the Study

    This study is being conducted to evaluate the effects of the MarsMen Natural Testosterone Support supplement on men's health over a three-month period. The study aims to assess changes in testosterone levels, physical function, and anxiety levels using measures such as the Men’s Health Blood Test, PROMIS Physical Function – Short Form 10a Survey, and the General Anxiety Disorder (GAD-7) scale. The findings from this study will contribute to scientific knowledge regarding natural testosterone enhancement and its potential benefits to men's health.

    What You Will Do as Part of this Study

    While participating in this research study, you will need to:

    • Be willing and able to follow the study directions and procedures
    • Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
    • Ask questions as you think of them, via help@efforia.com or online chat.
    • Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

    Participant Responsibilities and Tasks

    As a participant in the MarsMen Testosterone Support 3-Month Evaluation, you will be engaged in a series of structured activities designed to assess the effects of the MarsMen Natural Testosterone Support supplement. Your commitment to the schedule and timeline is crucial for the success of the study.

    Overall Schedule and Timeline

    The study extends over a period of three months. During this time, you are expected to:

    • Take the MarsMen supplement daily to ensure consistent intake for optimal results.
    • Participate in scheduled assessments including the Men's Health Blood Test and SF-36 Survey to evaluate changes in testosterone levels, vitality, and quality of life.

    Treatment Activities

    Your participation will include the following activities:

    • Daily intake of the MarsMen supplement as per instructions.
    • Periodic assessments using the PROMIS Physical Function – Short Form 10a and General Anxiety Disorder (GAD-7) scale.
    • Regular measurements of vitality and energy levels.

    Measurement Frequency

    Assessments will be conducted at specified intervals throughout the study to accurately monitor changes and gather comprehensive data.

    Adherence to Timeline

    Strict adherence to the timeline is imperative to ensure the validity and reliability of the study outcomes. Please ensure you follow the schedule meticulously and complete all tasks as outlined. Your participation and commitment are highly valued.

    The Risks, Discomforts & Benefits of Being in this Study

    There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

    Consider your Own Risk-Benefit Comfort Level

    It is important to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

    Personal and Overall Findings

    Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember that participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.

    Possible Benefits of Participation

    Participants might experience improvements in testosterone levels, physical vitality, and reduced anxiety. The study contributes to broader scientific understanding, which may eventually lead to more effective health solutions. However, there is a possibility that there will be no measurable benefit to the participant, other than seeing reports that the intervention or treatment had no measurable impact.

    Possible Serious Adverse Events & Side Effects

    Introduction and Summary of Known Risks

    The MarsMen Natural Testosterone Support supplement is designed to enhance testosterone levels and improve men's health through a 3-month evaluation period. This report contains a detailed analysis of the risks associated with the use of MarsMen Natural Testosterone Support and the Men’s Health Blood Test. The evaluation also includes various health scales and tests to monitor changes and effects.

    The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

    In the Case of an Adverse Event

    If you experience any severe reactions or symptoms while using MarsMen Natural Testosterone Support or during any related testing, seek immediate medical attention by calling 911. Once any acute situation has been addressed, please also inform Efforia about the event so that we can take appropriate measures and provide further assistance.

    Serious Adverse Events (SAEs)

    Theoretical side effects Relative incidence Recovery
    Incidence of Cancer Very low likelihood Not applicable
    Exacerbation or escalation to acute or chronic disease Low likelihood Corrects after discontinuation
    Death None Not applicable
    Life-threatening experience Very low likelihood Corrects after discontinuation
    Hospitalization (initial or prolonged) Low likelihood Corrects after discontinuation
    Disability or permanent damage Very low likelihood Potentially permanent
    Congenital anomaly/birth defect None Not applicable
    Required intervention to prevent permanent impairment or damage Low likelihood Corrects after discontinuation
    Frustration and irritation Medium likelihood Subsides with use

    Efforia's Limitations in Providing Direct Medical Support

    Efforia provides technology-based data collection and analysis but does not offer direct medical treatment or emergency medical services. Users are advised to contact their healthcare provider or emergency services in the event of severe health issues.

    Long-term Dependence Issues

    Long-term dependence on MarsMen Natural Testosterone Support has not been extensively studied; however, there may be a psychological dependence due to perceived improvements in vitality and energy.

    Legality for Use by Various Institutions

    The legality of MarsMen Natural Testosterone Support in sports and professional settings has not been fully established. Users should check with governing bodies like the World Anti-Doping Association, National Collegiate Athletic Association, and their respective workplace policies to ensure compliance and avoid potential conflicts.

    Privacy & Security Risks

    We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: Efforia Privacy Policy

    • We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
    • Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

    What to do if you have a study related injury

    If you have a study-related injury, you should seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia in case you experience any problems, have any side effects, or have any study-related injury after you've received any necessary treatment. We want to make sure others are aware of potential risks.

    Study related injury care and compensation

    Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

    In the case of medical emergency

    In the cace of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

    Alternatives to Participating in the Study

    Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right, or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

    Your Rights as a Participant

    Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

    Privacy and Confidentiality

    You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

    Right to Your Own Results

    Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

    The Right to Leave a Study without Penalty at Any time

    If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

    Conflict of Interest Statement

    As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

    Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

    How we Reduce Conflicts of Interest

    It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

    Consequences of Conflict of Interest Non-Compliance

    Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform and payments may not be refunded.

    By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

    Data Protections

    Efforia is committed to ensuring that your data is collected, used, and protected in compliance with data protection laws.

    What you can do to improve your privacy and security

    As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: Efforia Privacy Policy.

    Who will have access to your data?

    Efforia will have access to your data. There may be partners who also have access to your data, such as labs and connected health devices.

    What will we do with your data

    We will use the data to show you your own personal results, and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

    California Experiential Research Subject’s Bill of Rights

    For more information about your rights as a participant, please refer to the Efforia Privacy Policy.

    Who to Contact for Questions or Concerns

    If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:
    HELP@EFFORIA.COM
    (646) 679-2479
    OR CLICK THE CHAT BUTTON ON YOUR SCREEN
    If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
    If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.
    Univo IRB
    4509 Creedmoor Road
    Suite 403
    Raleigh, NC 27612
    info@univo-group.com
    (919) 910-7743

    Additional questions and closing

    Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study. If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.

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