Welcome. You are invited to take part in a research study hosted on the Efforia platform. This study is designed to help you test a 90-day protocol and track what changes for you using structured check-ins, measurements, and lab testing. Please read this consent form carefully. It is meant to help you decide whether you want to participate.

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. You may leave the study at any time without penalty by emailing help@efforia.com.

Please ask any questions you have before you decide. You can contact help@efforia.com or use the online chat. If any part of this study does not make sense for your personal situation, do not join.

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.

The purpose of this study is to evaluate how a 90-day estrogen-balance supplement protocol may relate to changes in body composition, anxiety symptoms, and hormone-related laboratory values, while also building real-world safety evidence.

This is a single-arm, longitudinal study. That means there is no separate control group. You act as your own control by comparing your own baseline measures to your follow-up measures over time.

Products and services in this study (definitions):

• Estrogen Balance Formula – Hormetics Weight Optimization System (3 bottles): A dietary supplement product taken as two capsules daily with your last meal. (Note: A full ingredient list and safety details should be reviewed on the product label and any manufacturer materials before you enroll. If you cannot access the ingredient list, do not join.)
• Comprehensive Women’s Health Blood Test (Tasso self-collection device): A shoulder-attached, minimally invasive blood collection device that collects a small sample for lab analysis. You mail the sample back in the provided pre-paid envelope. This study includes two tests (baseline and follow-up).

Outcome measures in this study (definitions):

• Body Composition Measurement Form: A structured self-report form where you enter body measurements (for example: weight and circumference measures such as hips/waist, as applicable).
• General Anxiety Disorder 7-item scale (GAD-7): A standardized 7-question screening tool about anxiety symptoms.
• Women’s Health Blood Test panel: A lab panel assessing:
  • DHEA-S (Dehydroepiandrosterone sulfate)
  • Estradiol
  • Progesterone
  • FSH (Follicle Stimulating Hormone)
  • LH (Luteinizing Hormone)

Important note: This study is for research and self-learning purposes. It is not medical care and is not a substitute for diagnosis or treatment by your clinician.

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 you complete enrollment and payment, and after you enter your personal details, shipping details (for the supplement and the blood test kit), and your communication preferences, your participation will include the activities below for approximately 90 days:

• Baseline (Getting Started / Your Baseline Measurements):
  • Welcome to the Estrogen Balance Protocol
  • Your Goals & Expectations
  • Your Baseline Anxiety Levels (GAD-7)
  • Your Baseline Body Composition Measurement (Body Composition Measurement Form)
  • Your Blood Test (Comprehensive Women’s Health Blood Test panel)
• Daily Routine (throughout the program):
  • Take 2 capsules of the Estrogen Balance Formula daily with your last meal.
  • Complete Safety & Adverse Event Check-ins as prompted.
• Follow-up Measurements:
  • Body Composition Measurement – Day 45
  • General Anxiety Disorder (GAD-7) (as scheduled in the protocol tasks)
  • Body Composition Measurement – Day 90
  • Your Follow Up Blood Test (Comprehensive Women’s Health Blood Test panel)

If you have questions at any time, contact help@efforia.com or use the online chat.

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

Possible Serious Adverse Events & Side Effects

Some People May be at Increased Risk

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

Consider your Own Risk-Benefit Comfort Level

Before you enroll, carefully weigh the possible risks and possible benefits of participation. This study places more responsibility on you to make the right choice than a traditionally sponsored clinical trial, because you are choosing to participate and you are paying for the bundled items used in the study.

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 is 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: https://efforia.com/privacy-policy/

There may be certain limits to the rights of your privacy:

• 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.

The Possible Benefits of ParticipatingPersonal and Overall Findings

Efforia will provide the participant 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 the participants interest and willingness to be involved in the study. Remind them that participation is voluntary and they may exit at any time with an e-mail to help@efforia.com.

At the end of the possible benefits of participation section, 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.

If you believe you have a study-related injury or a concerning side effect, seek local medical care first, if necessary. Efforia can not provide emergency medical care or diagnosis. However, it is very important to contact Efforia in the 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 aware of potential risks.

Study related injury care and compensation

Efforia will not offer financial compensation nor 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 study related injury as a result of participation in this study.

In the case of medical emergency

In the case 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.

Explain to the participant that since this study is for research only, the only other choice would be not to be in the study. Explain to the participant if this study does not seem quite right, or to expensive for their specific purposes, Efforia is dedicated to making other studies available. They may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate. You may choose to participate in another protocol instead.

Ethical Considerations: 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.

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.

Privacy and Confidentiality: The researchers will only use and share information that is needed for the study. Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records. Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose of using and sharing your information is to make sure the study is done properly.

By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.

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.

If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.

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.

How Efforia Makes Money on this protocol: Efforia takes a transaction fee on all the products and services included in this protocol. Explicitly explain that 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: You also have a role in reducing conflicts of interest as well. 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 they 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.

Describe how data will be collected, used, and protected, ensuring compliance with data protection laws. Data includes questionnaire responses, body measurements, and lab results you receive through the Women’s Health Blood Test.

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: https://efforia.com/privacy-policy.

Who will have access to your data? Efforia will have access to your data. And that there may be partners who also have access to your data (like 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.

Tell participants about the California Experiential Research Subject Bill of Rights. For more information about privacy and confidentiality, review Efforia’s privacy policy here: https://efforia.com/privacy-policy/

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

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.