Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

NCT04091789 | Unknown Phase 2 DMC

• 1 other identifier: PG-19-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

Conditions

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

Keywords

Pain Associated with Dysmenorrhea; CBD; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Two Months

• The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.

  Two Months

• Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.

  Two Months

• Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire

  Two Months

Study Arms (1)

Test Article

EXPERIMENTAL

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

Interventions

Pure Femme Tablets DRUG

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.

Test Article

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Qualifying subjects must have regular, predictable menstrual cycles that range in length between 21-35 days.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pure Green: lead

Study Sites (1)

Dr. Nakadar's Office

Sterling Heights, Michigan, 48310, United States

RECRUITING

Related 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.

  PMID: 10600789 BACKGROUND

• 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.

  PMID: 18722817 BACKGROUND

• 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.

  PMID: 19237109 BACKGROUND

• Harel Z. Dysmenorrhea in adolescents and young adults: etiology and management. J Pediatr Adolesc Gynecol. 2006 Dec;19(6):363-71. doi: 10.1016/j.jpag.2006.09.001.

  PMID: 17174824 BACKGROUND

• 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.

  PMID: 24266425 BACKGROUND

• 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.

  PMID: 8532266 BACKGROUND

• Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014:0813.

  PMID: 25338194 BACKGROUND

• Latthe P, Latthe M, Say L, Gulmezoglu 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. doi: 10.1186/1471-2458-6-177.

  PMID: 16824213 BACKGROUND

• 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. doi: 10.1136/bmj.38748.697465.55. Epub 2006 Feb 16.

  PMID: 16484239 BACKGROUND

• 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. doi: 10.1016/s1701-2163(16)30395-4. English, French.

  PMID: 16524531 BACKGROUND

• 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.

  PMID: 20091521 BACKGROUND

• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

  PMID: 16690671 BACKGROUND

• 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.

  PMID: 24030561 BACKGROUND

• 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.

  PMID: 18559804 BACKGROUND

• 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.

  PMID: 24746919 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Migraine Disorders; Fatigue; Nausea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive

Study Officials

• Debra Kimless, M.D.

  Pure Green

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Denham

CONTACT

(228) 327-6339; hdenham@pure.green

Debra Kimless, M.D.

CONTACT

(248) 920-8761; dkimlessmd@pure.green

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: September 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)