Recruiting
Phase 2

Cannabinoid Combinations

Sponsor:

Pure Green

Code:

NCT04091789

Conditions

Dysmenorrhea

Headache, Migraine

Fatigue

Nausea

Mood Disturbance

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Pure Femme Tablets

Study Details

Brief summary:

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Conditions

Dysmenorrhea

Headache, Migraine

Fatigue

Nausea

Mood Disturbance

Study ID

NCT04091789

Start date

Sep, 2019

Status verified date

Sep, 2019

Completion date

May, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Impact of Pure Green tablet on menstrual pain as measured by a pain scale score [ Time Frame: Two Months ]

Central Contacts and Locations

Central contacts

Locations

Dr. Nakadar's Office

Recruiting

Sterling Heights, Michigan, United States, 48310

Contacts

More Information

Sponsor

Pure Green

Last update posted

Sep 19, 2019

Last verified

Sep, 2019

Keywords

  • Pain Associated with Dysmenorrhea
  • CBD
  • Cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pure Green on 2019-09-19.