EndometriosisPhase 2NCT06477406
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
A Phase 2 study testing Cannabidiol in people with Endometriosis, run by Mclean Hospital at 1 site in United States.
Trial summary
Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent
- Sex assigned female at birth
- Subject is 21 or older
- Subject is fluent in English
- Subject endorses at least moderate levels of pain at the baseline visit
- Subject endorses having endometriosis
Who cannot join
- Non-fluent English speakers
- Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
- Currently uses cannabis or cannabinoid products regularly
- Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
- Neuropathic pain or cancer-related pain
- Disclosure of a genetic polymorphism affecting CYP2C9 function
Trial locations and contacts
1 site in 1 country.
About this study
Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.
Read the detailed description
Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.
This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.
- Conditions
- Endometriosis
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.
PlaceboDrug
An active placebo containing supplemental terpenes matched to the high-CBD product.
| Study group | Role | What they receive |
|---|---|---|
| High-CBD Sublingual Product | Experimental | A custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The VAS is a commonly used pain scale where patients draw a line to indicate their pain level on a 100 millimeter long line anchored by two verbal descriptors for symptom extremes (e.g. "no pain" to "worst imaginable pain"). The VAS will be used to describe different types of endometriosis-related pain (dysmenorrhea (pain during menstruation), dyspareunia (pain during or after intercourse), and non-menstrual chronic pelvic pain). Lower scores indicate less pain.
Measured: 12 weeks
Secondary outcomes (7)
Endometriosis Health Profile (EHP-30)
The EHP-30 is a well-validated self-report scale with 30 core items and 23 additional questions related to specific modules and areas of life often impacted by endometriosis symptoms. Lower scores indicate fewer symptoms.
Measured: 12 weeks
VAS-IBS
The VAS-IBS queries bowel-related concerns. While initially developed for IBS patients, it is commonly used to assess gastrointestinal symptoms in endometriosis patients. Lower scores indicate fewer bowel symptoms.
Measured: 12 weeks
Beck Anxiety Inventory (BAI)
The BAI is a 21 item-self-report measure that can be used to screen for anxiety. Each item on the BAI is rated on a scale of 0 to 3, and is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Lower scores indicate fewer symptoms of anxiety.
Measured: 12 weeks
Beck Depression Inventory (BDI)
The BDI is a 21 item-self-report measure that can be used to assess the severity of depression. Each item on the BDI relates to a symptom of depression and is rated by the subject using a 0-3 scale. Lower scores indicate fewer depressive symptoms.
Measured: 12 weeks
Conventional Medication Use
Changes in conventional medication use will be assessed over the course of treatment with study product.
Measured: 12 weeks
Inflammatory Biomarkers
Saliva samples will be used to quantify levels of common inflammatory markers (e.g. IL-1β, IL-6, IL-8, TNF-α). Lower levels of inflammatory markers indicate less systemic inflammation.
Measured: 12 weeks
Circulating Endocannabinoid Concentrations
Plasma will be analyzed for circulating levels of endocannabinoids and related compounds (e.g., AEA, 2-AG, 2-OG, PEA, OEA).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start27 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Life Sciences Center
- Responsible party
- Principal investigator, Staci Gruber, Ph.D., Mclean Hospital
- Investigators
- Staci Gruber, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477406
- Sponsor's protocol ID
- 2024P001549
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
- ClinicalTrials.gov ID
- NCT06477406
- Acronym / sponsor ID
- 2024P001549
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Life Sciences Center
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.
Detailed description
Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.
This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-CBD Sublingual Product | Experimental | Drug: CannabidiolA custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has provided informed consent
- Sex assigned female at birth
- Subject is 21 or older
- Subject is fluent in English
- Subject endorses at least moderate levels of pain at the baseline visit
Key exclusion criteria (7 listed)
- Non-fluent English speakers
- Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
- Currently uses cannabis or cannabinoid products regularly
- Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolCustom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes. | Drug | High-CBD Sublingual Product |
| PlaceboAn active placebo containing supplemental terpenes matched to the high-CBD product. | Drug | Placebo |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12 weeks
The VAS is a commonly used pain scale where patients draw a line to indicate their pain level on a 100 millimeter long line anchored by two verbal descriptors for symptom extremes (e.g. "no pain" to "worst imaginable pain"). The VAS will be used to describe different types of endometriosis-related pain (dysmenorrhea (pain during menstruation), dyspareunia (pain during or after intercourse), and non-menstrual chronic pelvic pain). Lower scores indicate less pain.
7 secondary outcomes
Endometriosis Health Profile (EHP-30)
Time frame: 12 weeks
VAS-IBS
Time frame: 12 weeks
Beck Anxiety Inventory (BAI)
Time frame: 12 weeks
Beck Depression Inventory (BDI)
Time frame: 12 weeks
Conventional Medication Use
Time frame: 12 weeks
Inflammatory Biomarkers
Time frame: 12 weeks
Circulating Endocannabinoid Concentrations
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
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Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staci Gruber, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Endometriosis, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.