Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Fatigue Clinical Trial

Official title:

A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091789
• Other study ID #: PG-19-003
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2019
• Est. completion date: May 2020

Study information

• Verified date: September 2019
• Source: Pure Green
• Contact: Heather Denham
• Phone: (228) 327-6339
• Email: hdenham[@]pure.green
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Dr. Nakadar's Office	Sterling Heights	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pure Green

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. — View 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. — View Citation

Harel Z. Dysmenorrhea in adolescents and young adults: etiology and management. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):363-71. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014. pii: 0813. Review. — View Citation

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. — View Citation

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. — View Citation

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two Months
Secondary	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.	Two Months
Secondary	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.	Two Months
Secondary	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.	Two Months
Secondary	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.	Two Months