DysmenorrheaPhase 2NCT04091789
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
A Phase 2 study testing Pure Femme Tablets in people with Dysmenorrhea and Headache, Migraine, run by Pure Green at 1 site in United States.
Trial summary
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Dysmenorrhea, Headache, Migraine, Fatigue
- What is being tested?
- Pure Femme Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2019to May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr. Nakadar's Office
Sterling Heights, Michigan, 48310
Heather Denham, 228-327-6339, hdenham@pure.green
Matthew Caloura, (248) 802-4380, mcaloura@pure.green
About this study
Official title: A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
- Conditions
- Dysmenorrhea, Headache, Migraine, Fatigue, Nausea, Mood Disturbance
- Being tested
- Pure Femme Tablets
- Keywords
- Pain Associated with Dysmenorrhea, CBD, Cannabidiol
- Medical subject headings
- Dysmenorrhea, Migraine Disorders, Fatigue, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure Femme TabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pure Femme Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Two Months
The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.
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.
Measured: Two Months
Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.
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.
Measured: Two Months
Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire
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.
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pure Green
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Kimless, M.D., Principal investigator, Pure Green
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091789
- Sponsor's protocol ID
- PG-19-003
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10600789Chantler 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.
PubMed 18722817Dorn 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.
PubMed 19237109Harel 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.
PubMed 17174824Iacovides 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.
PubMed 24266425Jamieson 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.
PubMed 8532266Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014:0813.
PubMed 25338194Latthe 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.
PubMed 16824213Latthe 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.
PubMed 16484239Lefebvre 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.
PubMed 16524531Marjoribanks 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.
PubMed 20091521Proctor 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.
PubMed 16690671Stegeman 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.
PubMed 24030561Wang 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.
PubMed 18559804Zannoni 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.
PubMed 24746919
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
- ClinicalTrials.gov ID
- NCT04091789
- Acronym / sponsor ID
- PG-19-003
- Conditions
- Dysmenorrhea, Headache, Migraine, Fatigue, Nausea, Mood Disturbance
- Keywords
- Pain Associated with Dysmenorrhea, CBD, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pure GreenIndustry (pharma, biotech, devices)
- Study start
- Sep 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Article | Experimental | Drug: Pure Femme TabletsSubjects 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure Femme TabletsA 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. | Drug | Test Article |
Primary outcome
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.
4 secondary outcomes
The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.
Time frame: Two Months
The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.
Time frame: Two Months
Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.
Time frame: Two Months
Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire
Time frame: Two Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Background: PubMed 10600789Baker 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.
- Background: PubMed 18722817Chantler 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.
- Background: PubMed 19237109Dorn 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.
- Background: PubMed 17174824Harel 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.
- Background: PubMed 24266425Iacovides 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.
- Background: PubMed 8532266Jamieson 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.
- Background: PubMed 25338194Latthe PM, Champaneria R. Dysmenorrhoea. BMJ Clin Evid. 2014 Oct 21;2014:0813.
- Background: PubMed 16824213Latthe 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.
- Background: PubMed 16484239Latthe 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.
- Background: PubMed 16524531Lefebvre 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.
- Background: PubMed 20091521Marjoribanks 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.
- Background: PubMed 16690671Proctor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kimless, M.D. principal investigator
Pure Green
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pure Femme Tablets in people with Dysmenorrhea and Headache, Migraine, run by Pure Green at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Denham ((228) 327-6339, hdenham@pure.green), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Pure Green tablet on menstrual pain as measured by a pain scale score (time frame: Two Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091789, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.