Cannabidiol and Management of Endometriosis Pain

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT04527003
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol (CBD) Extract — DRUG
    Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
  • Norethindrone Acetate — DRUG
    Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
  • Placebo — OTHER
    a substance or treatment which is designed to have no therapeutic value

Study Details

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.

Key Dates

Start date
Dec 4, 2020
Status verified
Apr 2025
Primary completion
May 29, 2024
Completion
Jun 26, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group A - Placebo
    Norethindrone acetate (5mg daily) + Placebo
  • Active Comparator: Group B - Low Dose CBD
    Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
  • Active Comparator: Group C - High Dose CBD
    Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)

Primary Outcome Measure

Pain Score Area Under the Curve (AUC) [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033-

Related coverage on Hipa.ai

Find similar trials in Hershey, PA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Penn State Health Milton S. Hershey Medical Center· Hershey, PA

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