Clinical trial NCT04091789: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dysmenorrhea
Headache, Migraine
Fatigue
Nausea
Mood Disturbance
Keywords: Pain Associated with Dysmenorrhea
CBD
Cannabidiol
Lead sponsor: Pure Green
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea


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.

Primary outcomes:
measure: Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
timeFrame: Two Months
Secondary outcomes:
measure: The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.
timeFrame: Two Months
measure: The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.
timeFrame: Two Months
measure: Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.
timeFrame: Two Months
measure: Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire
timeFrame: Two Months
Other outcomes:
Locations:
city: Sterling Heights
country: United States
facility: Dr. Nakadar's Office
state: Michigan
Study officials:
affiliation: Pure Green
name: Debra Kimless, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.