Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04091789|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dysmenorrhea Headache, Migraine Fatigue Nausea Mood Disturbance||Drug: Pure Femme Tablets||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Test Article
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
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.
- 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.
- The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses. [ Time Frame: Two Months ]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.
- The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain. [ Time Frame: Two Months ]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.
- Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire. [ Time Frame: Two Months ]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.
- Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire [ Time Frame: Two Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091789
|Contact: Heather Denham||(228) firstname.lastname@example.org|
|Contact: Debra Kimless, M.D.||(248) email@example.com|
|Principal Investigator:||Debra Kimless, M.D.||Pure Green|