Phase
Condition
Pain
Oral Facial Pain
Chronic Pain
Treatment
N/AClinical Study ID
Ages > 21 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is female and at least 21 years of age;
Subject has a regular, predictable menstrual cycle ranging in length from 21-35 days;
Subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5or greater;
Subject is willing to provide her informed consent via DocuSign to participate in thestudy as stated in the informed consent document.
Subject knows how to use and is willing to use a smart phone app to recordinformation.
Exclusion
Exclusion Criteria:
Subject is pregnant or lactating;
Subject has an allergy to cannabis (marijuana), the Cannabaceae plant family (e.g.,hemp, hops), PEA, terpenes, citrus, or lavender, peppermint;
Subject has a known allergy to active or inert ingredients of Pure Femme tablets;
Subject is taking a concomitant medication or treatment that would complicate use orinterpretation of the study drug's effects (examples include: Cannabis or anycannabinoid products including CBD and THC; Any drug or herbal product that influencesthe endocannabinoid system (ECS));
Subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis,leiomyomata, or chronic pelvic pain;
Subject has a history of migraines, tension headaches, or cluster headaches notassociated with menstruation or is currently taking medication for headache treatmentor prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants,triptans);
Subject is currently using any of the following medications or classes of medicationroutinely: opioids, anti-emetics, acetaminophen, NSAIDS, ergotamines, triptans, or,glucocorticoids;
Subject has shortness of breath associated with allergies;
Subject has uncontrolled asthma;
Subject has a fever and/or productive cough.
Study Design
Connect with a study center
Dr. Nakadar's Office
Sterling Heights, Michigan 48310
United StatesActive - Recruiting
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