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Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091789
Recruitment Status : Unknown
Verified September 2019 by Pure Green.
Recruitment status was:  Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pure Green

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Period Pain

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Impact of Pure Green tablet on menstrual pain as measured by a pain scale score [ Time Frame: 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 :
  1. The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses. [ Time Frame: 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.

  2. The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain. [ Time Frame: 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.

  3. Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire. [ Time Frame: 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.

  4. Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Qualifying subjects must have regular, predictable menstrual cycles that range in length between 21-35 days.
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091789


Contacts
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Contact: Heather Denham (228) 327-6339 hdenham@pure.green
Contact: Debra Kimless, M.D. (248) 920-8761 dkimlessmd@pure.green

Locations
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United States, Michigan
Dr. Nakadar's Office Recruiting
Sterling Heights, Michigan, United States, 48310
Contact: Heather Denham    228-327-6339    hdenham@pure.green   
Contact: Matthew Caloura    (248) 802-4380    mcaloura@pure.green   
Sub-Investigator: Saqib Nakadar, D.O.         
Sponsors and Collaborators
Pure Green
Investigators
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Principal Investigator: Debra Kimless, M.D. Pure Green
More Information
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Publications:

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Responsible Party: Pure Green
ClinicalTrials.gov Identifier: NCT04091789    
Other Study ID Numbers: PG-19-003
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pure Green:
Pain Associated with Dysmenorrhea
CBD
Cannabidiol
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Dysmenorrhea
Pain
Neurologic Manifestations
Menstruation Disturbances
Pathologic Processes
 Pelvic Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases