Trial | NCT04091789  Report issue

Title

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Study Started
Sep 30
2019
Anticipated
Primary Completion
Mar 31
2020
Anticipated
Study Completion
May 31
2020
Anticipated
Last Update
Sep 19
2019

Drug Pure Femme Tablets [cannabidiol (Epidiolex), tetrahydrocannabinol]

A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene, beta-caryophyllene, humulene, linalool, and limonene and peppermint oil.

Test Article Experimental

Subjects will take Pure Femme sublingual tablets as directed, one tablet 2 days before, one tablet 1 day before, and then up to 3 tablets per day for 3 days (72 hours) during menstruation.

Criteria 

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 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 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 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.
No Results Posted