Menstrual DiscomfortPhase 2NCT05679830
The Effects of CBD Isolate on Menstrual-Related Symptoms
A Phase 2 study testing Cannabidiol in people with Menstrual Discomfort, run by Canopy Growth Corporation at 1 site in United States.
Trial summary
The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Discomfort
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 23 Sep 2021
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is at least 18 years old.
- Participant is willing and able to provide informed consent and participate in the study for 4 months.
- Participant experiences a regular period (occurring every 21-38 days and lasting between 4-8 days).
- Participant is diagnosed with Pre-menstrual Dysphoric Disorder or scores at least '30' on the Menstrual-Related Symptom Questionnaire
- Participant is willing to begin tracking their periods and menstrual symptoms for the duration of the study
- Participant agrees to abide by all study restrictions and comply with all study procedures.
Who cannot join
- Participant has a known history of significant allergic condition, significant hypersensitivity to CBD, or allergic reaction to cannabis, cannabinoid medications, or excipients of the drug product.
- Participant has been exposed to any investigational drug or device < 30 days prior to screening or plans to take another investigational drug at any time during the study.
- Participant has self-reported using cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD or Tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Participant has a current or past primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis that the Investigator(s) determines would interfere in treatment or interfere in evaluation of the study treatment (e.g., current psychotic disorder).
- Participant is currently prescribed medications with known THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, Mammalian target of rapamycin (mTOR) inhibitors, oral tacrolimus).
- Participant is trying to get pregnant.
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- Participant is pregnant.
- Participant has a history of suicide attempt in the last year.
- Participant endorses current suicidal plan and intent during screening.
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study.
- Participant has a BMI of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above).
Trial locations and contacts
1 site in 1 country.
United States1 site
James Madison University
Harrisonburg, Virginia, 22801
About this study
Official title: A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms
The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is:
(1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption.
Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).
- Conditions
- Menstrual Discomfort
- Being tested
- Cannabidiol
- Keywords
- cannabidiol, CBD, menstruation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.
| Study group | Role | What they receive |
|---|---|---|
| 160mg Cannabidiol Isolate | Experimental | 320mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS). Receives: Drug: Cannabidiol |
| 320mg Cannabidiol Isolate | Experimental | 160mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS). Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual-Related Symptoms Questionnaire (MRSQ)
Change in menstrual-related symptoms from baseline scores as measured by the MRSQ every cycle for three cycles. Scores range from 26-104, with higher scores representing greater severity of symptoms.
Measured: 1 menstrual cycle/1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start23 Sep 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual DiscomfortStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- James Madison University
- Responsible party
- Sponsor
- Investigators
- Jessica G Irons, PhD, Principal investigator, James Madison University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679830
- Sponsor's protocol ID
- MRS
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms
- ClinicalTrials.gov ID
- NCT05679830
- Acronym / sponsor ID
- MRS
- Conditions
- Menstrual Discomfort
- Keywords
- cannabidiol, CBD, menstruation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Collaborators
- James Madison University
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 11 Jan 2023 (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.
The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is:
(1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption.
Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 160mg Cannabidiol Isolate | Experimental | Drug: Cannabidiol320mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS). |
| 320mg Cannabidiol Isolate | Experimental | Drug: Cannabidiol160mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant is at least 18 years old.
- Participant is willing and able to provide informed consent and participate in the study for 4 months.
- Participant experiences a regular period (occurring every 21-38 days and lasting between 4-8 days).
- Participant is diagnosed with Pre-menstrual Dysphoric Disorder or scores at least '30' on the Menstrual-Related Symptom Questionnaire
- Participant is willing to begin tracking their periods and menstrual symptoms for the duration of the study
Key exclusion criteria (11 listed)
- Participant has a known history of significant allergic condition, significant hypersensitivity to CBD, or allergic reaction to cannabis, cannabinoid medications, or excipients of the drug product.
- Participant has been exposed to any investigational drug or device < 30 days prior to screening or plans to take another investigational drug at any time during the study.
- Participant has self-reported using cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD or Tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Participant has a current or past primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis that the Investigator(s) determines would interfere in treatment or interfere in evaluation of the study treatment (e.g., current psychotic disorder).
- Participant is currently prescribed medications with known THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, Mammalian target of rapamycin (mTOR) inhibitors, oral tacrolimus).
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 |
|---|---|---|
| CannabidiolCannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant. | Drug | 160mg Cannabidiol Isolate, 320mg Cannabidiol Isolate |
Primary outcome
Menstrual-Related Symptoms Questionnaire (MRSQ)
Time frame: 1 menstrual cycle/1 month
Change in menstrual-related symptoms from baseline scores as measured by the MRSQ every cycle for three cycles. Scores range from 26-104, with higher scores representing greater severity of symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
Jessica G Irons, PhD principal investigator
James Madison University
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 Cannabidiol in people with Menstrual Discomfort, run by Canopy Growth Corporation 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual-Related Symptoms Questionnaire (MRSQ) (time frame: 1 menstrual cycle/1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.