The Effects of CBD Isolate on Menstrual-Related Symptoms

NCT05679830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-01-11

No results posted yet for this study

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).

Conditions

  • Menstrual Discomfort

Interventions

DRUG

Cannabidiol

Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Sponsors & Collaborators

  • James Madison University

    collaborator OTHER
  • Canopy Growth Corporation

    lead INDUSTRY

Principal Investigators

  • Jessica G Irons, PhD · James Madison University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679830 on ClinicalTrials.gov