Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

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

Tracking Information

• First Submitted Date: September 13, 2019
• First Posted Date: September 17, 2019
• Last Update Posted Date: September 19, 2019
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: 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
• Brief Summary: Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Dysmenorrhea
• Headache, Migraine
• Fatigue
• Nausea
• Mood Disturbance

Intervention

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

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 *

• Baker FC, Driver HS, Rogers GG, Paiker J, Mitchell D. High nocturnal body temperatures and disturbed sleep in women with primary dysmenorrhea. Am J Physiol. 1999 Dec;277(6):E1013-21. doi: 10.1152/ajpendo.1999.277.6.E1013.
• 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.
• 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.
• Harel Z. Dysmenorrhea in adolescents and young adults: etiology and management. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):363-71. Review.
• Iacovides S, Avidon I, Bentley A, Baker FC. Reduced quality of life when experiencing menstrual pain in women with primary dysmenorrhea. Acta Obstet Gynecol Scand. 2014 Feb;93(2):213-7. doi: 10.1111/aogs.12287. Epub 2013 Nov 25.
• 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.
• Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014. pii: 0813. Review.
• Latthe P, Latthe M, Say L, Gülmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. Review.
• Latthe P, Mignini L, Gray R, Hills R, Khan K. Factors predisposing women to chronic pelvic pain: systematic review. BMJ. 2006 Apr 1;332(7544):749-55. Epub 2006 Feb 16. Review.
• Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, Lea R, Robert M; SOGC. Primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2005 Dec;27(12):1117-46. English, French.
• Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD001751.
• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. Review.
• Stegeman BH, de Bastos M, Rosendaal FR, van Hylckama Vlieg A, Helmerhorst FM, Stijnen T, Dekkers OM. Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis. BMJ. 2013 Sep 12;347:f5298. doi: 10.1136/bmj.f5298. Review.
• Wang T, Collet JP, Shapiro S, Ware MA. Adverse effects of medical cannabinoids: a systematic review. CMAJ. 2008 Jun 17;178(13):1669-78. doi: 10.1503/cmaj.071178. Review.
• Zannoni L, Giorgi M, Spagnolo E, Montanari G, Villa G, Seracchioli R. Dysmenorrhea, absenteeism from school, and symptoms suspicious for endometriosis in adolescents. J Pediatr Adolesc Gynecol. 2014 Oct;27(5):258-65. doi: 10.1016/j.jpag.2013.11.008. Epub 2014 Apr 18.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2019): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2020
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• 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: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Heather Denham; (228) 327-6339; hdenham@pure.green

Contact: Debra Kimless, M.D.; (248) 920-8761; dkimlessmd@pure.green

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04091789
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Pure Green
• Study Sponsor: Pure Green
• Collaborators: Not Provided

Investigators

• Principal Investigator: Debra Kimless, M.D.; Pure Green

• PRS Account: Pure Green
• Verification Date: September 2019