Status:
UNKNOWN
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Lead Sponsor:
Pure Green
Conditions:
Dysmenorrhea
Headache, Migraine
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
Brief Summary
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Eligibility Criteria
Inclusion
- 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 5 or greater;
- Subject is willing to provide her informed consent via DocuSign to participate in the study as stated in the informed consent document.
- Subject knows how to use and is willing to use a smart phone app to record information.
Exclusion
- 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 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));
- 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 not associated with menstruation or is currently taking medication for headache treatment or prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants, triptans);
- Subject is currently using any of the following medications or classes of medication routinely: 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04091789
Start Date
September 1 2019
End Date
May 1 2020
Last Update
September 19 2019
Active Locations (1)
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1
Dr. Nakadar's Office
Sterling Heights, Michigan, United States, 48310