FREE HER Study

Finding Relief from Endometriosis and Exclusion: Hemp Extract Research

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FREE HER Study FAQ

This study was created to help women Find Relief from Endometriosis and Exclusion (FREE HER). Its purpose is to help us learn how medications and other substances can reduce complaints of pelvic pain and related issues.

Everyone has an Endocannabinoid System (ECS), an internal network that helps our bodies’ self-regulating processes, also known as homeostasis. The ECS influences many essential functions – inflammation, mood, sleep, coordination, and more. The ECS has a significant presence on female reproductive organs and plans a crucial role in women’s health. CBD may help the body to soothe aches, ease symptoms, and improve mood, mobility and overall quality of life.

To participate, you must meet all of the following Inclusion Criteria:
  • Female sex
  • Minimum age 18 years old
  • Current complaints of pelvic pain, which may include painful periods, pain with sexual activity, vaginal pain, endometriosis, or adenomyosis
  • Ability to read and write in English
  • Access to text messaging or email

However, you cannot participate if you meet any part of the following Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • Pregnancy in previous 90 days
  • Current diagnosis of urinary tract infection, pelvic inflammatory disease, or other acute gynecological infections.
  • Initiation and/or discontinuation of hormonal contraception, cooper intrauterine device, GnRh analogues, hormone replacement therapy, or pain medication in previous 90 days
  • Initiation, discontinuation, or change in dose of antidepressant, antipsychotic, or anxiolytic medications in previous 90 day
  • Currently trying to get pregnant
  • Concurrent use of carbamazepine or anti-seizure medications, lithium, or warfarin
  • Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine,neurologic or hematologic disease
  • History of hypersensitivity or allergy to cannabinoids, shea butter, or hemp seed oil
  • Recent gynecological or abdominal surgery

Note: If you do not meet the Criteria but will shortly (example: you will be 18 in two months) let your provider know and call their office when you are eligible.

We plan to enroll 300 participants. Each participant will be in the study for about one week.

If you are interested in joining the study, review the section “Who Can Participate?” If you meet the criteria, go to www.reserach.net/r/freeherconsent. Read and sign the Electronic Informed Consent. We encourage you to read it thoroughly. Once completed, you will be redirected to the enrollment page, but please wait to answer it after your medical appointment. You can either keep your browser open until you leave your appointment or go to the enrollment page later that day. The URL link will be listed for you on the last page of the Informed Consent. We will also email the study links to the email you provide for your Informed Consent. Please add [email protected] to your email contacts to ensure you receive our email and it does not go to spam.

Note: If you do not meet the Criteria but will shortly (example: you will be 18 in 2 months) let your provider know and call their office when you are eligible.

We want to hear about your experience! Those interested and eligible will first complete an informed consent. Study participants will then receive one bottle of CBD cream, a $70 retail value. Use of the cream is entirely voluntary. You can remain in the study whether you choose to use the cream or not.

As a participant, you will receive daily email reminders prompting you to answer surveys over the next week. The surveys will ask about current treatments (including over the counter and prescription medications), level of pain and functioning, and quality of life. The first survey (Enroll/Day1) will take about 15 minutes to complete. After that, daily surveys should take less than 5 minutes and will continue for either 1 week or 1 month (your choice). Upon completion of 7 surveys, you will receive a $15 gift card. If you continue the study and complete 30 surveys, you will receive an additional $15 gift card (totaling $30).

There are no treatments or procedures as part of this study. The risks associated with this study are minimal.

You will answer certain questions throughout the study, using our subcontractor SurveyMonkey. We have an agreement with SurveyMonkey’s parent company that requires it to hold your information in compliance with privacy and security laws and regulations. Records of participation in this study will be held confidential except when sharing the information is required by law or as described in this informed consent. The laws state that people including the Investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) may see and review study records at any time. This means that absolute confidentiality cannot be guaranteed.

However, in a research study, people may not see the study results or other data about the study until after the research is completed unless the study doctor decides otherwise. If the results of this study are published or presented at meetings, participants will not be identified. To protect participant identity, we will assign a study ID and code all identifying information separately from the study data that are collected. A computer file that has the links between study IDs and identifying information will be kept within a password-protected folder on a secure computer system. The digital software is HIPAA compliant to protect your information.

Study participants will receive one bottle of CBD (hemp extract cream), a $70 retail value. The hemp cream is a currently marketed, over-the-counter supplement. It is your choice whether or not to use the hemp cream. You may remain in the study regardless of using the cream or not and can answer surveys for either 1 week or 1 month (your choice). Upon completion of 7 surveys, you will receive a $15 gift card. If you continue the study and complete 30 surveys, you will receive an additional $15 gift card (totaling $30).

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns, or complaints about the study, please contact the Investigator via the Clinical Project Manager (information below). If you seek emergency care, or hospitalization is required, alert the Health Care Provider treating you during that time that you are participating in this research study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, contact: Study Subject Adviser Advarra IRB.

Mail:    6940 Columbia Gateway Drive

            Suite 110

            Columbia, MD 21046

Phone: 877-992-4724

Email:  [email protected]

If you have any questions not answered above, contact the Ananda Clinical Project Manager, Andrea Deweese.

Mail:    190 Corporate Boulevard

            Georgetown, KY 40324

Phone: 859-429-1979

Email:  [email protected]

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Medical Professional giving Bliss Product to Client

For more information on CBD for Women’s Health, visit this page.

Please Note: Product comes with applicator.