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    Important Information

    Summary Information to Help You Decide Whether to Join This Study

    INFORMED CONSENT DOCUMENT
    AGREEMENT TO BE IN A RESEARCH STUDY
    Study Title The Clubhouse Stud Protocol Trial
    Study Author Efforia study team and study collaborators from Club House Supplements and Adam Health
    Sponsor This study is made possible by your payment to join.
    Cost of Products, Services & Information to Participant US $458. You may have already paid some or all of this amount.
    Included Products & Services One bottle of Clubhouse “Stud” Formula; one Adam Sensor nocturnal erection tracker; access to the Adam mobile application; Efforia study tasks, questionnaires, reminders, safety check-ins, and personal and overall study reports.
    Outcome Measures Patient-Reported Outcomes Measurement Information System (PROMIS®) Satisfaction With Sex Life; Aging Male Symptoms Scale; International Index of Erectile Function; Adam Sensor measures of nocturnal penile tumescence; goals and expectations; self-reported sexual behavior, pornography use, drive, energy, mood, mental clarity, adherence, and safety information.
    Expected Participation Approximately 90 days, including baseline measures, daily supplement use, nocturnal Adam Sensor measurements, recurring check-ins, and a 30-day pornography-abstinence phase. The Efforia course-duration field currently displays 42 days, but the participant instructions and outcome windows describe an approximately 90-day study.
    Contact help@efforia.com

    👍 The table above provides a summary. You may sign now and continue, or read more detail below.

    Introduction & Summary

    You are invited to join a research study on the Efforia platform, made possible by your participation and financial contribution. The study will examine whether daily use of the Clubhouse “Stud” Formula, overnight tracking with the Adam Sensor, and a later 30-day period of pornography abstinence are associated with changes in sexual satisfaction, erectile function, age-related symptoms, nocturnal erections, mood, energy, mental clarity, and related behaviors.

    You may want to participate because you are interested in structured self-tracking and receiving personal and overall study findings. You may not want to participate because the study costs $458, requires repeated sensitive questionnaires and use of a sensor around the penis while sleeping, asks you to take a dietary supplement daily, and includes a 30-day attempt to abstain from pornography. The supplement’s complete ingredient list and study-specific safety profile are not contained in the current Efforia study record; this creates uncertainty about side effects, allergies, and interactions. The Adam Sensor is a general-wellness consumer device, not a medical device, and its results do not diagnose or treat disease. Neither benefit nor improvement is guaranteed.

    Your participation is voluntary. You may decline or leave at any time without penalty or loss of benefits to which you are otherwise entitled. Ask questions and resolve any uncertainty before signing. Review the supplement label and discuss participation with a qualified healthcare professional who knows your medications and health history, especially if you have any medical condition or use prescription drugs, over-the-counter medicines, or other supplements.

    Efforia is a citizen science platform where studies are effectively sponsored by, you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

    Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

    Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

    Purpose of the Study

    The purpose is to evaluate changes over time in adult men’s sexual health, sexual satisfaction, erectile function, age-related symptoms, nocturnal erection patterns, and self-reported behavior while participants use the Clubhouse “Stud” Formula and later attempt pornography abstinence. Clubhouse “Stud” Formula is a dietary supplement marketed for male sexual performance. Participants are instructed to take two capsules daily with food. This research does not establish that the product is safe or effective, and the product is not being used to diagnose, treat, cure, or prevent disease.

    The Adam Sensor is a lightweight wearable placed around the base of the flaccid penis during sleep. It records nocturnal penile tumescence—erections that occur while sleeping—and communicates with the Adam mobile application. It is a consumer general-wellness product and not a medical device. The study also uses the PROMIS® Satisfaction With Sex Life measure, the Aging Male Symptoms Scale, and the International Index of Erectile Function, along with behavioral and safety check-ins. These questionnaires measure participant-reported experiences; they are not a medical diagnosis.

    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.

    After enrollment, payment, entry of personal and shipping details, and selection of communication preferences, you will receive the supplement and Adam Sensor. You will complete baseline questions about your goals, satisfaction with sex life, aging-male symptoms, erectile function, and sexual behavior. You will download the Adam application and wear the charged sensor around the base of your flaccid penis during designated nights while sleeping. Do not include the scrotum in the straps.

    You will take two Clubhouse “Stud” Formula capsules each day with food, complete recurring behavior and safety check-ins, and report adherence and problems honestly. Later, you will begin a 30-day pornography-abstinence experiment. For this study, pornography means media whose primary purpose is sexual arousal; mainstream entertainment containing sex scenes is not treated as pornography. Masturbation and partnered sex are not prohibited. If you view pornography, report it honestly; it does not automatically end your participation. You will complete follow-up questionnaires and Adam Sensor measurements near the end of the study.

    The Risks, Discomforts & Benefits of Being in This Study

    This study has risks, discomforts, and possible benefits that you should understand. Because the supplement ingredient list and study-specific safety profile are absent from the current study record, the likelihood and full range of supplement-related risks cannot be determined from the information available.

    Possible Serious Adverse Events & Side Effects

    Risk name Risk likelihood Summary
    Allergic reaction to supplement Unknown A supplement ingredient could cause rash, swelling, breathing difficulty, or a severe allergic reaction requiring urgent care.
    Drug, supplement, or health-condition interaction Unknown An ingredient may interact with medicines, other supplements, alcohol, or a health condition; the complete ingredient list is not available in the study record.
    Digestive or general side effects Unknown The supplement may cause nausea, stomach upset, diarrhea, constipation, headache, dizziness, sleep changes, anxiety, or other unexpected symptoms.
    Cardiovascular or sexual-function effects Unknown Some ingredients marketed for sexual performance may affect blood pressure, heart rate, arousal, erections, or ejaculation.
    Adam Sensor pressure or skin effects Low Overnight wear may cause pressure, chafing, skin irritation, numbness, pain, sleep disruption, or temporary discomfort; remove it immediately if symptoms occur.
    Distress or embarrassment Medium Questions and tracking concern erections, pornography, masturbation, partnered sex, mood, and other sensitive experiences.
    Changes during pornography abstinence Unknown Attempting abstinence may cause frustration, cravings, shame, irritability, distress, or relationship tension; you may stop the experiment or leave the study.
    Incorrect interpretation of wellness data Medium Sensor and questionnaire results may be misunderstood and must not replace medical evaluation or treatment.
    Loss of privacy Low Despite safeguards, sensitive sexual-health, behavioral, contact, and device data could be disclosed through error, unauthorized access, or a security incident.

    Some People May Be at Increased Risk

    Some people may be at increased risk and should not join before speaking with a medical or other professional with intimate knowledge of their specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated products and services outside the study.

    Who may be at increased risk Why they should not join without professional approval
    Anyone pregnant, thinking of becoming pregnant, or breastfeeding The supplement and device have not been evaluated for pregnancy or breastfeeding, and the study is designed for adult males using a penile sensor.
    People under 18 The study is intended only for adults.
    People with allergies or sensitivities to any labeled supplement ingredient Exposure could cause an allergic reaction.
    People using prescription medicines, over-the-counter medicines, or other supplements Unknown ingredients or doses may interact with other substances, particularly medicines affecting blood pressure, the heart, mood, hormones, erections, or bleeding.
    People with cardiovascular, blood-pressure, bleeding, liver, kidney, hormonal, psychiatric, neurologic, urologic, penile, or significant sleep conditions The supplement, sensor, or study procedures may worsen symptoms, interact with treatment, or create misleading results.
    People with penile injury, implants, skin disease, pain, reduced genital sensation, impaired circulation, or difficulty removing the device independently Overnight sensor wear could increase the risk of pressure, injury, skin problems, or delayed recognition of harm.
    People whose pornography use causes significant distress, compulsive behavior, relationship harm, or mental-health symptoms Abstinence and repeated questioning may increase distress; appropriate clinical support may be more suitable than research participation.

    Consider Your Own Risk-Benefit Comfort Level

    Carefully weigh the possible risks, burdens, costs, and benefits. This participant-funded citizen-science model places more responsibility on you to decide whether the study is appropriate than a traditionally sponsored clinical 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.

    Privacy & Security Risks

    Efforia uses safeguards intended to keep data private and confidential, but no system can eliminate all risk. Review the Efforia Privacy Policy. Efforia may contact local emergency services or other appropriate help if it has reason to believe you may harm yourself or others. Regulators, including the U.S. Food and Drug Administration or similar agencies, the Efforia Institutional Review Board, and other authorized research-monitoring bodies may review records containing identifying information.

    The Possible Benefits of Participating: Personal and Overall Findings

    Efforia will provide personal outcomes and overall findings at various data-collection points or as findings become available. These findings may affect your interest in continuing. Participation remains voluntary, and you may leave at any time by emailing help@efforia.com. You may learn about patterns in your own sexual-health questionnaires, behaviors, and nocturnal erection data, and pooled findings may contribute to broader knowledge. These are research and general-wellness results, not a diagnosis. There may be no measurable benefit other than receiving reports showing that the intervention had no measurable impact.

    What to Do if You Have a Study-Related Injury

    Seek local medical care first whenever necessary. Efforia cannot provide emergency medical care or diagnosis. After you receive any necessary treatment, contact help@efforia.com promptly about any problem, side effect, or study-related injury so the study team can document the event and alert others to potential risks.

    Study-Related Injury Care and Compensation

    Efforia will not offer financial compensation nor absorb the costs of medical treatment should you experience a study-related injury as a result of participation in this study. Efforia makes no commitment to provide free medical care or payment for a study-related injury as a result of participation in this study.

    In the Case of Medical Emergency

    In a medical emergency, 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 you may be a danger to yourself or others, dial or text 988 for the Suicide & Crisis Lifeline. Help is available.

    Alternatives to Participating in the Study

    This study is for research, not medical treatment. You may choose not to participate, may use neither product, may discuss nonresearch alternatives with a qualified healthcare professional, or may obtain products or services separately outside the study. If this study is not right for you or is too expensive, click the Efforia logo at the top of the page to explore other studies.

    Your Rights as a Participant

    Ethical considerations and participant rights: Efforia states that it upholds research ethics standards while hosting this participant-funded study. Your participation is voluntary. Refusing will not alter your usual healthcare or involve any penalty or loss of benefits to which you are entitled. If you join, you may withdraw at any time and for any reason without penalty or loss of benefits. You are not giving up legal rights by signing this document.

    Privacy and Confidentiality

    You have a right to privacy and confidentiality. Researchers will use and share only information needed for the study and will protect it as required by law. Absolute confidentiality cannot be guaranteed because authorized people outside the study team may need to inspect study records. These may include the Efforia Institutional Review Board and agencies, committees, and offices that review or monitor research. By signing, you authorize Efforia to use and share your health information as described here. If you do not sign, you cannot participate.

    Right to Your Own Results

    You have the right to an explanation of the research after your involvement concludes, including relevant information about any controls or other study design features. Individual results will be provided under the conditions described by Efforia, but they are not medical diagnoses.

    The Right to Leave a Study Without Penalty at Any Time

    You may withdraw at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave,” or by contacting help@efforia.com. Consumable products not yet shipped will be refunded. Non-consumable products may qualify for a full refund after return in accordance with the applicable return policy. Data already collected may remain in the study records as permitted by law and approved study procedures; ask Efforia how withdrawal affects future collection and use of your data.

    New Information and Study Results

    If study information is published or presented, your identity will not be revealed. If significant new information becomes available that may affect the risks, benefits, or your willingness to participate, you will be notified so you can decide whether to continue.

    Conflict of Interest Statement

    This citizen-science study is hosted by Efforia and funded through participant payments. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes. Efforia receives a transaction fee on products and services included in the protocol. Aside from that fee, Efforia reports no financial interest or conflict related to the results. Efforia will send one enrollment reminder if you do not finish enrollment and will not remarket or otherwise pressure you to join.

    How We Reduce Conflicts of Interest

    You must disclose and avoid financial relationships with intervention or measurement providers used in the study. Employees, investors, stakeholders, product representatives, and protocol authors connected with Club House Supplements, Adam Health, Efforia, or related entities should disclose that relationship before participating because it may compromise study integrity.

    Consequences of Conflict of Interest Non-Compliance

    Failure to disclose a conflict may result in removal from the study or suspension from the platform, and payments may not be refunded as permitted by applicable policies and law.

    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 will collect account and contact information, questionnaire responses, study-task completion, safety reports, purchase and shipping information, and Adam Sensor/app data made available for the study. Data will be used to operate the study, show personal results, analyze pooled outcomes, monitor safety and quality, meet legal and oversight obligations, and communicate study information. Efforia uses administrative, technical, and organizational safeguards and processes data under applicable privacy and data-protection requirements, but no safeguard can guarantee absolute security.

    What You Can Do to Improve Your Privacy and Security

    You will receive email, SMS, or push notifications when questionnaires, reminders, and other tasks are ready. You may adjust communication preferences in Efforia. If you do not want study notifications, do not press Accept and do not join. Protect your phone, computer, and email with a password, PIN, or other access control; do not share accounts or passwords. Learn more in the Efforia Privacy Policy.

    Who Will Have Access to Your Data?

    Efforia will have access. Limited data may also be available to authorized study authors, IRB and regulatory reviewers, service providers, Club House Supplements for product fulfillment when needed, Adam Health and its app/service providers for device operation, and other partners necessary to conduct or oversee the study. Their access should be limited to what is needed for their role.

    What Will We Do With Your Data?

    Efforia will use the data to show personal results and combine results with those of other participants to report general outcomes. Reports and publications will not identify you by name. The study does not collect biospecimens. Identifiers may be removed from your private information; de-identified information may then be retained, analyzed, used in future related research, or shared with other investigators without additional consent, as permitted by law and IRB-approved procedures. Efforia will not publicly use information connected with your name or another direct identifier without your permission.

    California Experimental Subject’s Bill of Rights

    If you are a California participant, state law provides additional research-subject rights. Before consenting, you have the right to understand the nature and purpose of the experiment; procedures and drugs or devices used; reasonably expected risks, discomforts, benefits, and alternatives; available treatment if complications arise; whom to contact; and your right to withdraw without prejudice. You should receive a copy of this consent. See the Efforia Privacy Policy for privacy information.

    Questions or Concerns

    This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
    If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
    ETHICS@EFFORIA.COM

    For study questions, side effects, problems, or research-related injury reports, contact help@efforia.com.

    Additional Questions and Closing

    Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for 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.

    Consent acknowledgment: By signing electronically, you confirm that you are at least 18 years old; have read and understood this document; have had the opportunity to ask questions; voluntarily agree to participate; authorize the described collection, use, and sharing of your study and health information; and understand that you may withdraw at any time without penalty or loss of benefits to which you are otherwise entitled.

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