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Trial record 1 of 1 for:    menstruation, Canopy Growth Corporation | CBD
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The Effects of CBD Isolate on Menstrual-Related Symptoms

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. Read our disclaimer for details. Identifier: NCT05679830
Recruitment Status : Completed
First Posted : January 11, 2023
Last Update Posted : January 11, 2023
James Madison University
Information provided by (Responsible Party):
Canopy Growth Corporation

Brief 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). 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).

Condition or disease Intervention/treatment Phase
Menstrual Discomfort Drug: Cannabidiol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms
Actual Study Start Date : September 23, 2020
Actual Primary Completion Date : September 23, 2021
Actual Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: 160mg Cannabidiol Isolate
320mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS).
Drug: Cannabidiol
Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Experimental: 320mg Cannabidiol Isolate
160mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS).
Drug: Cannabidiol
Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Participant is at least 18 years old.
  2. Participant is willing and able to provide informed consent and participate in the study for 4 months.
  3. Participant experiences a regular period (occurring every 21-38 days and lasting between 4-8 days).
  4. Participant is diagnosed with Pre-menstrual Dysphoric Disorder or scores at least '30' on the Menstrual-Related Symptom Questionnaire
  5. Participant is willing to begin tracking their periods and menstrual symptoms for the duration of the study
  6. Participant agrees to abide by all study restrictions and comply with all study procedures.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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).
  5. 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).
  6. Participant is trying to get pregnant.
  7. Participant is pregnant.
  8. Participant has a history of suicide attempt in the last year.
  9. Participant endorses current suicidal plan and intent during screening.
  10. 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.
  11. Participant has a BMI of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above).

Information from the National Library of Medicine

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 identifier (NCT number): NCT05679830

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United States, Virginia
James Madison University
Harrisonburg, Virginia, United States, 22801
Sponsors and Collaborators
Canopy Growth Corporation
James Madison University
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Principal Investigator: Jessica G Irons, PhD James Madison University
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Responsible Party: Canopy Growth Corporation Identifier: NCT05679830    
Other Study ID Numbers: MRS
First Posted: January 11, 2023    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Canopy Growth Corporation:
Additional relevant MeSH terms:
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