UnknownPhase 2

Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea

United States30 participantsStarted 2019-09

Plain-language summary

Age range21 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

Impact of Pure Green tablet on menstrual pain as measured by a pain scale score

Timeframe: Two Months

NCT IDNCT04091789

SponsorPure Green

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03

Heather Denham

Who can participate

Age range21 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;