Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Status unconfirmed · Phase 2

Conditions studied: Dysmenorrhea, Headache, Migraine, Fatigue, Nausea, Mood Disturbance

In brief

Key facts

Study ID: NCT04091789
Run by: Pure Green
People needed: 30
Starts: 2019-09-01
Expected to finish: 2020-05-01
Last updated by the study team: 2019-09-19

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Dr. Nakadar's Office — Sterling Heights, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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