What side effects are associated with this type of intervention?

Common treatments for endometriosis, such as estrogen-progestin contraceptives, progestin-only therapies, and GnRH agonists/antagonists, often have side effects including nausea, weight gain, mood changes, and decreased libido. Estrogen-progestin contraceptives can also cause headaches and an increased risk of blood clots. Progestin-only therapies may lead to irregular bleeding and bone density loss. GnRH agonists/antagonists are associated with menopausal-like symptoms such as hot flashes, night sweats, and decreased bone density. Cannabinoids, while less commonly used, may cause dizziness, dry mouth, and potential cognitive effects.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies to manage pain and reduce lesion size. These include gonadotropin-releasing hormone (GnRH) agonists, such as leuprolide, which suppress estrogen production, and progestins like norethindrone acetate, which inhibit endometrial tissue growth. Aromatase inhibitors, such as letrozole, have also been used to lower estrogen levels. While these treatments are effective in managing symptoms, they often come with significant side effects. Cannabidiol (CBD), currently under investigation for its analgesic and anti-inflammatory properties, represents a different approach by potentially targeting pain and inflammation without the hormonal side effects associated with traditional therapies.

What other types of research exist?

Promising novel alternatives to Cannabidiol (CBD) for endometriosis patients include: 1) Selective cannabinoid receptor agonists targeting CB1 and CB2 receptors, which have shown potential in modulating pain and inflammation. 2) Nabilone, a synthetic cannabinoid, which has demonstrated efficacy in pain management. 3) Emerging non-cannabinoid therapies such as selective progesterone receptor modulators (SPRMs) and GnRH antagonists, which are being studied for their ability to reduce endometriosis-related pain and inflammation.

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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)

Must not have

Women with known liver disease, such as hepatitis, or with screening LFTS (AST/ALT) > 3 times above the upper limits of normal (ULN) in the past year

History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing CBD to see if it can help reduce pain and improve the quality of life for patients with endometriosis. The study will compare different doses of CBD over a few months. Researchers believe CBD may work by affecting the body's natural systems that control pain and inflammation. CBD has been shown to significantly improve pain intensity in some studies, although evidence quality is low due to high risk of bias and small sample sizes.

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.

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.

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

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I am a woman aged between 18 and 45.

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I have been diagnosed with endometriosis through surgery, and I experience significant pain from it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman with liver disease or my liver tests have been high in the past year.

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I have had a stroke or heart attack.

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I have not had suicidal thoughts or uncontrolled depression in the last year.

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I have or might have breast cancer based on a physical exam.

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I am a woman currently using Clobazam or Valproate and cannot stop for the study.

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I am a woman who uses opioids daily for a chronic pain condition other than endometriosis.

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I have used cannabis products within the last 30 days.

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My BMI is over 35.

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I am currently using a contraceptive implant that contains progestin.

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I am not pregnant, breastfeeding, or trying to conceive.

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I regularly take medication that makes me sleepy and cannot stop for the study.

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I drink more than 3 alcoholic beverages daily on average.

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I have had or currently have deep vein thrombosis or a lung clot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Score

Secondary study objectives

Change in EHP-30 Core Domain

Change in Total FSFI Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis focus on reducing pain and inflammation, which are primary symptoms of the condition. Cannabidiol (CBD) is being studied for its potential analgesic and anti-inflammatory effects. CBD interacts with the endocannabinoid system, which plays a role in pain modulation and immune response. By binding to cannabinoid receptors (CB1 and CB2) found in endometriotic lesions, CBD may help reduce pain and inflammation. This is significant for endometriosis patients as it offers a potential non-opioid alternative for managing chronic pain, which can improve quality of life and reduce reliance on more traditional pain medications that may have significant side effects.

Detection of Cannabinoid Receptor Expression by Endometriotic Lesions in Women with Endometriosis as an Alternative to Opioid-Based Pain Medication.The cannabinoid receptor CB1 contributes to the development of ectopic lesions in a mouse model of endometriosis.