Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Last updated: September 17, 2019
Sponsor: Pure Green
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Oral Facial Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04091789
PG-19-003
  • Ages > 21
  • Female

Study Summary

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Eligibility Criteria

Inclusion

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 5or greater;

  4. Subject is willing to provide her informed consent via DocuSign to participate in thestudy as stated in the informed consent document.

  5. Subject knows how to use and is willing to use a smart phone app to recordinformation.

Exclusion

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 orinterpretation of the study drug's effects (examples include: Cannabis or anycannabinoid products including CBD and THC; Any drug or herbal product that influencesthe 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 notassociated with menstruation or is currently taking medication for headache treatmentor prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants,triptans);

  7. Subject is currently using any of the following medications or classes of medicationroutinely: 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.

Study Design

Total Participants: 30
Study Start date:
September 01, 2019
Estimated Completion Date:
May 31, 2020

Connect with a study center

  • Dr. Nakadar's Office

    Sterling Heights, Michigan 48310
    United States

    Active - Recruiting

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