FREE HER Study

Finding Relief from Endometriosis and Exclusion: Hemp Extract Research

If you are a provider interested in enrolling patients in the FREE HER study, please complete the form on this page.

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FREE HER Study FAQ

The purpose of the FREE HER study is to learn more about how individual differences in use of medications and other substances impact the health and quality of life in individuals with complaints of moderate to severe chronic pelvic pain. Participants will be asked to complete a set of digital questionnaires to help us examine the associations between the use of substances and overall health and functioning.

Endocannabinoid receptors are abundant in female reproductive organs, and the central nervous system. Their signalling and trafficking influence multiple physiological and pathophysiological functions of female reproduction, including folliculogenesis, endometrial cell motility, endometrial migration & proliferation, and peripheral innervation associated with endometrial pain. Cannabinoid agonists exert antiproliferative effects on deep infiltrating endometriosis, and increased cannabinoid signalling may reduce proliferation of endometriotic lesions. Cannabinoid receptors in the pelvis, ovaries, endometrium, vulva, and the central and peripheral nervous systems influence inflammation, nociception, and arousal at these therapeutic targets. Cannabinoids trigger localized vasodilation and relaxation of pathological smooth muscle contraction and/or spasticity.

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 month.

Those eligible and interested in joining the study will need to read and sign an Electronic Informed Consent. The participant does not need to complete this in the office setting, but it may be helpful to do so. Please refer to the Health Care Provider Welcome Letter for detailed directions. This letter is included in the study kit, which will be mailed to your practice if you choose to help distribute the cream to participants.

Participants enrolled in the study will answer daily surveys. The first survey (Enroll/Day1) link will be emailed to them and take about 15 minutes to complete. Then participants will receive a daily email prompting them to answer the “Daily Survey”, which takes less than 5 minutes. Surveys will ask about current treatments (including over the counter and prescription medications), level of pain and functioning, and quality of life.

Upon completion of 7 surveys, participants who were sent cream through the mail will receive a $15 gift card. If they continue the study and complete 30 surveys, they will receive an additional $15 gift card (totaling $30). Participants who are given a cream by their provider will receive a $30 gift card upon completion of all 30 surveys.

There are no treatments or procedures as part of this study. The risks associated with this study are minimal. The main risk is loss of data confidentiality, as the study will collect information about your medical history, substance use (which may include illegal behaviors), and psychological health and physical functioning. Breach of confidentiality could lead to negative economic or social consequences, such as disapproval or social stigma associated with knowledge of mental health symptoms or behaviors.

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 their choice whether or not to use the hemp cream. They may remain in the study regardless of using the cream or not.

Upon completion of 7 surveys, participants who were sent cream through the mail will receive a $15 gift card. If they continue the study and complete 30 surveys, they will receive an additional $15 gift card (totaling $30). Participants who are given a cream by their provider (study kit) will receive a $30 Visa gift card upon completion of all 30 surveys.

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

Provider Study Registration

If you are a provider interested in enrolling patients in the FREE HER study, please complete the form on this page. A representative from the Ananda Health team will contact you with next steps.