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Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Primary Purpose

Dysmenorrhea, Headache, Migraine, Fatigue

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pure Femme Tablets
Sponsored by
Pure Green
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Pain Associated with Dysmenorrhea, CBD, Cannabidiol

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Dr. Nakadar's OfficeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Article

Arm 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.

Outcomes

Primary Outcome Measures

Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
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

The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.
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.
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.
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
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.

Full Information

First Posted
September 13, 2019
Last Updated
September 17, 2019
Sponsor
Pure Green
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1. Study Identification

Unique Protocol Identification Number
NCT04091789
Brief Title
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Official Title
A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pure Green

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Headache, Migraine, Fatigue, Nausea, Mood Disturbance
Keywords
Pain Associated with Dysmenorrhea, CBD, Cannabidiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Article
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pure Femme Tablets
Intervention Description
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 Information:
Title
Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
Description
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.
Time Frame
Two Months
Secondary Outcome Measure Information:
Title
The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.
Description
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.
Time Frame
Two Months
Title
The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.
Description
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.
Time Frame
Two Months
Title
Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.
Description
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.
Time Frame
Two Months
Title
Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire
Description
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.
Time Frame
Two Months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Qualifying subjects must have regular, predictable menstrual cycles that range in length between 21-35 days.
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is female and at least 21 years of age; Subject has a regular, predictable menstrual cycle ranging in length from 21-35 days; Subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5 or greater; Subject is willing to provide her informed consent via DocuSign to participate in the study as stated in the informed consent document. Subject knows how to use and is willing to use a smart phone app to record information. Exclusion Criteria: Subject is pregnant or lactating; Subject has an allergy to cannabis (marijuana), the Cannabaceae plant family (e.g., hemp, hops), PEA, terpenes, citrus, or lavender, peppermint; Subject has a known allergy to active or inert ingredients of Pure Femme tablets; 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)); Subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis, leiomyomata, or chronic pelvic pain; 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); Subject is currently using any of the following medications or classes of medication routinely: opioids, anti-emetics, acetaminophen, NSAIDS, ergotamines, triptans, or, glucocorticoids; Subject has shortness of breath associated with allergies; Subject has uncontrolled asthma; Subject has a fever and/or productive cough.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Denham
Phone
(228) 327-6339
Email
hdenham@pure.green
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Kimless, M.D.
Phone
(248) 920-8761
Email
dkimlessmd@pure.green
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, M.D.
Organizational Affiliation
Pure Green
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Nakadar's Office
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Denham
Phone
228-327-6339
Email
hdenham@pure.green
First Name & Middle Initial & Last Name & Degree
Matthew Caloura
Phone
(248) 802-4380
Email
mcaloura@pure.green
First Name & Middle Initial & Last Name & Degree
Saqib Nakadar, D.O.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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10600789
Citation
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Results Reference
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18722817
Citation
Chantler I, Mitchell D, Fuller A. Actigraphy quantifies reduced voluntary physical activity in women with primary dysmenorrhea. J Pain. 2009 Jan;10(1):38-46. doi: 10.1016/j.jpain.2008.07.002. Epub 2008 Aug 23.
Results Reference
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19237109
Citation
Dorn LD, Negriff S, Huang B, Pabst S, Hillman J, Braverman P, Susman EJ. Menstrual symptoms in adolescent girls: association with smoking, depressive symptoms, and anxiety. J Adolesc Health. 2009 Mar;44(3):237-43. doi: 10.1016/j.jadohealth.2008.07.018. Epub 2008 Oct 29.
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Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol. 1996 Jan;87(1):55-8. doi: 10.1016/0029-7844(95)00360-6.
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Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014:0813.
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Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

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