Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Sponsor

Pure Green (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04091789

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Headache, Migraine Fatigue Nausea Mood Disturbance	Drug: Pure Femme Tablets	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Article 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.	Drug: Pure Femme Tablets 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.

Arm

Intervention/Treatment

Experimental: Test Article

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.

Drug: Pure Femme Tablets

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.

Outcome Measures

Primary Outcome Measures

Impact of Pure Green tablet on menstrual pain as measured by a pain scale score [Two Months]
The study objective is to examine the impact on Pure Green tablet on menstrual related pain. Patients will self report their pain scale score using 0-10 scale where 0 is no pain and 10 is the worst pain ever.

Secondary Outcome Measures

The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses. [Two Months]
Subjective quality of life during menses will be measured by using the World Health Organization's Quality of Life (QOL) questionnaire. Patients will be asked a rating scale 1-5 where 1 is not at all and 5 is an extreme amount of elements such as health, enjoyment, happiness, concentration, energy levels, at the beginning and end of their menstrual cycle and results will be compared.
The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain. [Two Months]
Patients be asked which medications and doses are usually taken to treat menstrual related symptoms. During the trial, patients will document any additional medications taken and if so, the amount of the medications needed beyond the trial drug in order to treat their menstrual related symptoms. The results will be compared to what they originally documented as their usual therapeutic treatment.
Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire. [Two Months]
The Steiner rating scale will be used to evaluate mood disturbances during menses and the impact of Pure Green tablets on mood disturbances during menses. A scale of 0-4 where 0 is the absence of the mood and 4 is severe will be used to examine elements such as irritability, tension, dysphoria, fatiguability, coordination, cognitive functioning, eating habits, and social impairment. The results will be compared with a self-reported pre-study accounting of usual mood during menses.
Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire [Two Months]
Patients will be given a headache specific questionnaire before and after the trial to assess the impact of Pure Green tablets on menstrual related migraine or headache. The questionnaire is comprised of 4 yes or no questions asking about headache and or migraine related to menstruation. The results will be compared with the pre-study self reporting of headache or migraine during menstruation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.