NCT04091789UnknownPhase 2
A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
Pure Green1 site in 1 country30 target enrollmentStarted: September 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
Study Overview
Brief Summary
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Pure Femme Tablets (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.(Two Months)
- Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire(Two Months)
- Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.(Two Months)
- The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.(Two Months)
Investigators
Study Sites (1)
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