Cannabinoid-based product for gynecologic pain in endometriosis, adenomyosis, or PID
Official title: PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Run by Mclean Hospital · NCT07728695 · Data updated 2026-11-12
This study tests a high-CBD, hemp-derived product against placebo in adults with gynecologic pain from endometriosis, adenomyosis, or PID over one week to see if it reduces pain and related symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | January 2029 |
| Study ends | January 2029 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07728695 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 and older with endometriosis, adenomyosis, or chronic pelvic inflammatory disease and stable treatments who are willing to use a CBD product and participate in PK procedures if eligible.
✕Probably not a fit
Patients not experiencing gynecologic pain related to the qualifying conditions or those using cannabinoids currently are less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled trial evaluating a full-spectrum high-CBD sublingual product in individuals with gynecologic pain due to endometriosis, adenomyosis, or PID. Participants will undergo screening, baseline assessments, and a one-week treatment period with self-administered dosing, plus optional PK/PD studies with additional blood draws. The study includes three visits during the treatment week and may involve extra procedures for a PK subgroup, with compensation for those procedures. Primary outcomes focus on pain-related measures, while secondary assessments may cover safety and pharmacokinetic/pharmacodynamic relationships. The trial is sponsored by Staci Gruber, with NCCIH collaboration, conducted at McLean Hospital.
Why it matters
Potential benefit: If successful, the product could offer a new option to help reduce gynecologic pain for these conditions.
How similar studies have gone: Prior research in cannabinoid-based therapies for gynecologic pain is limited; this study explores a novel full-spectrum, high-CBD approach with placebo control.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
-
McLean Hospital
Belmont, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Staci Gruber, PhD
- Email: gruber@mclean.harvard.edu
- Phone: 617-855-2762
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Good pain consultation for endometriosis
This trial will test whether adding a 'good pain consultation' with early biopsychosocial pain education to usual care helps biological women with endometriosis manage pain and improve quality of life.
-
Effects of pelvic organ diseases on endometrial receptivity in infertile women
This study is trying to see how conditions like adenomyosis, fibroids, and endometriosis affect the ability of the uterus to support pregnancy in women who are having trouble getting pregnant.
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Measuring L-PGDS levels in blood, urine, vaginal fluid and endometrial tissue
This project will test whether L-PGDS levels in blood, urine, vaginal fluid and uterine tissue differ between women with adenomyosis, other benign uterine conditions, and healthy controls.
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Improving diagnosis of endometriosis and adenomyosis using advanced analysis techniques
This study is trying to find better ways to diagnose endometriosis and adenomyosis in women by using advanced techniques that look at genetics and imaging to help personalize treatments.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
-
Investigating the effects of diet and therapy on endometriosis pain
This study is testing whether an anti-inflammatory diet and therapy can help women with endometriosis feel less pain and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.