Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Inclusion Criteria:

 1. Subject is female and at least 21 years of age;

 2. Subject has a regular, predictable menstrual cycle ranging in length from 21-35 days;

 3. Subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5
 or greater;

 4. Subject is willing to provide her informed consent via DocuSign to participate in the
 study as stated in the informed consent document.

 5. Subject knows how to use and is willing to use a smart phone app to record
 information.

 Exclusion Criteria:

 1. Subject is pregnant or lactating;

 2. Subject has an allergy to cannabis (marijuana), the Cannabaceae plant family (e.g.,
 hemp, hops), PEA, terpenes, citrus, or lavender, peppermint;

 3. Subject has a known allergy to active or inert ingredients of Pure Femme tablets;

 4. Subject is taking a concomitant medication or treatment that would complicate use or
 interpretation of the study drug's effects (examples include: Cannabis or any
 cannabinoid products including CBD and THC; Any drug or herbal product that influences
 the endocannabinoid system (ECS));

 5. Subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis,
 leiomyomata, or chronic pelvic pain;

 6. Subject has a history of migraines, tension headaches, or cluster headaches not
 associated with menstruation or is currently taking medication for headache treatment
 or prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants,
 triptans);

 7. Subject is currently using any of the following medications or classes of medication
 routinely: opioids, anti-emetics, acetaminophen, NSAIDS, ergotamines, triptans, or,
 glucocorticoids;

 8. Subject has shortness of breath associated with allergies;

 9. Subject has uncontrolled asthma;

 10. Subject has a fever and/or productive cough.