CompletedPhase 2

The Effects of CBD Isolate on Menstrual-Related Symptoms

United States33 participantsStarted 2020-09-23

Plain-language 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).

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Menstrual-Related Symptoms Questionnaire (MRSQ)

Timeframe: 1 menstrual cycle/1 month

Trial details

NCT IDNCT05679830

SponsorCanopy Growth Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-23

View on ClinicalTrials.gov More Menstrual Discomfort trials