Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Pure Green Pharmaceuticals

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Pure Femme Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091789

PG-19-003

Details and patient eligibility

About

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Enrollment: 30 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is female and at least 21 years of age;
2. Subject has a regular, predictable menstrual cycle ranging in length from 21-35 days;
3. Subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5 or greater;
4. Subject is willing to provide her informed consent via DocuSign to participate in the study as stated in the informed consent document.
5. Subject knows how to use and is willing to use a smart phone app to record information.

Exclusion criteria

1. Subject is pregnant or lactating;
2. Subject has an allergy to cannabis (marijuana), the Cannabaceae plant family (e.g., hemp, hops), PEA, terpenes, citrus, or lavender, peppermint;
3. Subject has a known allergy to active or inert ingredients of Pure Femme tablets;
4. 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));
5. Subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis, leiomyomata, or chronic pelvic pain;
6. 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);
7. Subject is currently using any of the following medications or classes of medication routinely: opioids, anti-emetics, acetaminophen, NSAIDS, ergotamines, triptans, or, glucocorticoids;
8. Subject has shortness of breath associated with allergies;
9. Subject has uncontrolled asthma;
10. Subject has a fever and/or productive cough.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Test Article

Experimental group

Description:

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.

Treatment:

Drug: Pure Femme Tablets