EndometriosisPhase 1/2PAIN-GPNCT07728695
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
A Phase 1/2 study testing Custom-formulated, high-CBD study product in people with Endometriosis and Adenomyosis, run by Staci Gruber, Ph.D. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Endometriosis, Adenomyosis, Chronic Pelvic Inflammatory Disease
- What is being tested?
- Custom-formulated, high-CBD study product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2029
- Phase
- Phase 1/2
- 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
- Provides informed consent
- Sex assigned female at birth
- Capable of having menstrual cycles
- Aged 21+
- Endorses one of the following gynecologic pain conditions: endometriosis, adenomyosis, chronic pelvic inflammatory disease (PID)
- Stable medication/psychotherapy regimens for at least 3 months prior to starting the study, including hormonal contraceptives
- Additional inclusion criteria for those in the PK subgroup:
- Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)
Who cannot join
- Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder
- Currently uses cannabinoid products
- Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Presence of a serious or unstable medical illness, including liver/kidney disease, cardiovascular disease, neurological disorder, and conditions or medications that impact drug absorption or gastric emptying (e.g., GLP-1 agonists)
- Comorbid neuropathic pain or cancer-related pain
- Disclosure of a genetic polymorphism affecting CYP2C9 function
- Liver function test (LFT) values >3x the upper limit of normal (ULN) at the baseline visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Rosemary Smith, M.S., 617-855-2908, rsmith@mclean.harvard.edu
Staci Gruber, PhD
About this study
Official title: PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
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. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.
Read the detailed description
This study is a double-blind, placebo-controlled clinical trial of a high-cannabidiol (CBD) sublingual product in individuals with gynecologic pain relating to endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). The study consists of 3 visits. Participants will be pre-screened by phone to determine initial eligibility, then will come to McLean Hospital for a screening visit. During the screening visit, participants will complete a clinical interview, medical screening, a urine sample, blood draw, and a questionnaire. If approved, participants will come back to the hospital for a baseline visit, and will complete a urine sample, blood draw, questionnaires, and a sensory test. Enrolled participants will be randomized to receive one of two doses of high-CBD study product or placebo, and instructed to self-administer and track their use over the course of one week. Participants will return to the hospital for their final visit consisting of additional urine and blood samples, questionnaires, and sensory testing.
A subset of participants will have the option to complete pharmacokinetic/pharmacodynamic (PK/PD) studies, consisting of additional questionnaires and collection of blood samples through repeated blood draws before and after self-administration of the study product, at the baseline and final study visits. These additional procedures will take up to 8 hours per visit and participants who complete these procedures will receive additional compensation.
- Being tested
- Custom-formulated, high-CBD study product, Placebo
- Keywords
- cannabidiol, gynecologic pain, cannabinoid, endometriosis, adenomyosis, pelvic inflammatory disease
- Medical subject headings
- Endometriosis, Adenomyosis, Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-formulated, high-CBD study productDrug
2 doses of the high-CBD study product will be used, compared to placebo.
PlaceboDrug
Placebo study product.
| Study group | Role | What they receive |
|---|---|---|
| CBD study product: 1mL dose | Experimental | Participants in this arm will take 1mL of the CBD study product three times per day Receives: Drug: Custom-formulated, high-CBD study product |
| CBD study product: 0.5mL dose | Experimental | Participants in this arm will take 0.5mL of the CBD study product three times per day Receives: Drug: Custom-formulated, high-CBD study product |
| Placebo | Placebo comparator | Participants in this arm will take the placebo study product three times per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of parent CBD and its primary metabolites, 7-COOH-CBD and 7-OH-CBD, as well as metabolite-to-parent drug exposure ratios (MPR)
Measured: Baseline, 7 days
Inflammatory markers
Measured: Baseline, 7 days
Circulating anandamide (AEA)
Measured: Baseline, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staci Gruber, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Staci Gruber, Ph.D., Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728695
- Sponsor's protocol ID
- 2026P000409
- Acronym
- PAIN-GP
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study group may provide de-identified IPD to other researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
- ClinicalTrials.gov ID
- NCT07728695
- Acronym / sponsor ID
- PAIN-GP / 2026P000409
- Keywords
- cannabidiol, gynecologic pain, cannabinoid, endometriosis, adenomyosis, pelvic inflammatory disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Staci Gruber, Ph.D.University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Jul 2026 (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 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. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.
Detailed description
This study is a double-blind, placebo-controlled clinical trial of a high-cannabidiol (CBD) sublingual product in individuals with gynecologic pain relating to endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). The study consists of 3 visits. Participants will be pre-screened by phone to determine initial eligibility, then will come to McLean Hospital for a screening visit. During the screening visit, participants will complete a clinical interview, medical screening, a urine sample, blood draw, and a questionnaire. If approved, participants will come back to the hospital for a baseline visit, and will complete a urine sample, blood draw, questionnaires, and a sensory test. Enrolled participants will be randomized to receive one of two doses of high-CBD study product or placebo, and instructed to self-administer and track their use over the course of one week. Participants will return to the hospital for their final visit consisting of additional urine and blood samples, questionnaires, and sensory testing.
A subset of participants will have the option to complete pharmacokinetic/pharmacodynamic (PK/PD) studies, consisting of additional questionnaires and collection of blood samples through repeated blood draws before and after self-administration of the study product, at the baseline and final study visits. These additional procedures will take up to 8 hours per visit and participants who complete these procedures will receive additional compensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBD study product: 1mL dose | Experimental | Drug: Custom-formulated, high-CBD study productParticipants in this arm will take 1mL of the CBD study product three times per day |
| CBD study product: 0.5mL dose | Experimental | Drug: Custom-formulated, high-CBD study productParticipants in this arm will take 0.5mL of the CBD study product three times per day |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will take the placebo study product three times per day |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provides informed consent
- Sex assigned female at birth
- Capable of having menstrual cycles
- Aged 21+
- Endorses one of the following gynecologic pain conditions: endometriosis, adenomyosis, chronic pelvic inflammatory disease (PID)
Key exclusion criteria (7 listed)
- Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder
- Currently uses cannabinoid products
- Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Presence of a serious or unstable medical illness, including liver/kidney disease, cardiovascular disease, neurological disorder, and conditions or medications that impact drug absorption or gastric emptying (e.g., GLP-1 agonists)
- Comorbid neuropathic pain or cancer-related pain
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 |
|---|---|---|
| Custom-formulated, high-CBD study product2 doses of the high-CBD study product will be used, compared to placebo. | Drug | CBD study product: 0.5mL dose, CBD study product: 1mL dose |
| PlaceboPlacebo study product. | Drug | Placebo |
Primary outcome
Quantification of parent CBD and its primary metabolites, 7-COOH-CBD and 7-OH-CBD, as well as metabolite-to-parent drug exposure ratios (MPR)
Time frame: Baseline, 7 days
Inflammatory markers
Time frame: Baseline, 7 days
Circulating anandamide (AEA)
Time frame: Baseline, 7 days
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. The study group may provide de-identified IPD to other researchers upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Custom-formulated, high-CBD study product in people with Endometriosis and Adenomyosis, run by Staci Gruber, Ph.D. 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 8 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: looking for participants now, as of the sponsor's last update on 27 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Staci Gruber, PhD (617-855-2762, gruber@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of parent CBD and its primary metabolites, 7-COOH-CBD and 7-OH-CBD, as well as metabolite-to-parent drug exposure ratios (MPR) (time frame: Baseline, 7 days). The study lists 3 primary outcomes in all. 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 27 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.