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Trial record 3 of 8 for:    pure green

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT04091789
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pure Green

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 19, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Evaluate the impact of Pure Green tablets on the quality of life during menstruation as measured by the WHO QOL questionnaire. [ Time Frame: Two Months ]
    The objective is to evaluate subjective quality of life during menses by using the World Health Organization's Quality of Life (QOL) questionnaire. Patients will be asked at the beginning and end of their menstrual cycle and results will be compared.
  • Determine if Pure Green tablets Can reduce or replace usual treatment as self reported by the patient. [ Time Frame: Two Months ]
    The objective is to evaluate the impact of Pure Green tablets on usual therapeutic treatment of menstrual pain. Patients will be asked their usual treatment and will self report if treatment other than Pure Green tablets are needed for their menstrual related pain.
  • Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire. [ Time Frame: Two Months ]
    The objective is to assess Pure Green tablets' impact on mood disturbances during a menstrual cycle. The Steiner PMTS will be given pre and post trial and results will be compared to each other.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Official Title  ICMJE A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
Brief Summary Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dysmenorrhea
  • Headache, Migraine
  • Fatigue
  • Nausea
  • Mood Disturbance
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Pure Femme Tablets
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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.
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Denham (228) 327-6339 hdenham@pure.green
Contact: Debra Kimless, M.D. (248) 920-8761 dkimlessmd@pure.green
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091789
Other Study ID Numbers  ICMJE PG-19-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pure Green
Study Sponsor  ICMJE Pure Green
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Debra Kimless, M.D. Pure Green
PRS Account Pure Green
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP