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Cannabinoid

CBD for Endometriosis Pain

Phase 3
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females ages 18-45 years at the time of enrollment
A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis with associated moderate to severe endometriosis related pain ( > 3 on a VAS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights

Study Summary

This trial will study whether CBD can help relieve pain and improve quality of life for people with endometriosis.

Who is the study for?
This trial is for women aged 18-45 with a surgical diagnosis of endometriosis and moderate to severe pain. Participants must not be planning surgery, agree to use contraception, and can switch to Norethindrone acetate for the study duration. Exclusions include high BMI, liver disease, certain medication use, substance abuse issues, chronic opioid use for other pains, current cannabis product use or recent history thereof.Check my eligibility
What is being tested?
The study examines if CBD extract improves pain and quality of life in endometriosis patients over 12 weeks compared to a placebo. It includes onsite visits and daily assessments. Patients may also receive Norethindrone Acetate as part of their treatment regimen during the trial.See study design
What are the potential side effects?
Potential side effects from CBD could include fatigue, changes in appetite or weight, diarrhea, and possible interactions with other medications. Norethindrone Acetate might cause menstrual irregularities, headache, nausea/vomiting/dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 45.
Select...
I have been diagnosed with endometriosis through surgery, and I experience significant pain from it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Score
Secondary outcome measures
Change in EHP-30 Core Domain
Change in Total FSFI Score

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Group B - Low Dose CBDActive Control2 Interventions
Norethindrone acetate (5mg daily) + Low dose CBD (10mg sublingual daily)
Group II: Group C - High Dose CBDActive Control2 Interventions
Norethindrone acetate (5mg daily) + High dose CBD (20mg sublingual daily)
Group III: Group A - PlaceboPlacebo Group2 Interventions
Norethindrone acetate (5mg daily) + Placebo

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,806 Total Patients Enrolled
6 Trials studying Endometriosis
540 Patients Enrolled for Endometriosis

Media Library

Cannabidiol (CBD) Extract (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04527003 — Phase 3
Endometriosis Research Study Groups: Group B - Low Dose CBD, Group C - High Dose CBD, Group A - Placebo
Endometriosis Clinical Trial 2023: Cannabidiol (CBD) Extract Highlights & Side Effects. Trial Name: NCT04527003 — Phase 3
Cannabidiol (CBD) Extract (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527003 — Phase 3
Endometriosis Patient Testimony for trial: Trial Name: NCT04527003 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the risks associated with high doses of CBD?

"There is some efficacy data and multiple rounds of safety data available for Group C - High Dose CBD, so it received a score of 3."

Answered by AI

Are there previous examples of Group C - High Dose CBD's effectiveness?

"Currently, there are a total of 92 active clinical trials for Group C - High Dose CBD. Of these, 23 are in Phase 3. This treatment is being studied most extensively in Ribeirao Preto and Sao Paulo, Brazil; however, there are 931 research sites worldwide runningGroup C - High Dose CBD trials."

Answered by AI

Who meets the requirements to be a part of this experiment?

"This study is looking for 36 individuals aged 18 to 45 who suffer from pelvic pain caused by endometriosis. Eligible candidates must meet the following requirements: Be female, not be scheduled for any surgery related to endometriosis during the study, agree to use contraception if they are not sterile, be willing to switch their current medication to Norethindrone acetate (NETA) if necessary, have a surgical diagnosis of endometriosis that has been confirmed by visualization and/or histopathology with accompanying moderate to severe pain (>3 on VAS)."

Answered by AI

Are recruitment efforts for this trial ongoing?

"This study is not recruiting at this moment. It was initially posted on December 4th, 2020 and updated December 8th, 2021. For individuals looking for other studies, there are 136 clinical trials actively recruiting patients with pelvic pain and 92 trials for Group C - High Dose CBD searching for participants."

Answered by AI

Is this clinical trial open to patients who are legal adults?

"The age requirements for participants in this clinical trial are that individuals must be over 18 but under 45."

Answered by AI

How many people have been recruited for this clinical trial thus far?

"Unfortunately, this particular study is no longer taking patients. The trial was initially posted on December 4th 2020 and the listing was last updated on December 8th 2021. For other options, please note that there are 136 trials recruiting for pelvic pain and 92 studies looking for Group C - High Dose CBD participants."

Answered by AI

What are the main health concerns that Group C - High Dose CBD addresses?

"Group C - High Dose CBD is commonly used to treat contraception but it can also be prescribed for other conditions like female castration, oral contraceptives, and the vasomotor system."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Penn State Health Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Extreme pains and inability to take birth control due to side effects. Rapid growth.
PatientReceived 1 prior treatment
~2 spots leftby Jun 2024