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Studying a High-CBD Product for Gynecologic Pain

This study is looking at how a special high-CBD product (a type of cannabis compound) might help people with gynecologic pain caused by endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). Researchers want to understand how the product works in the body and if it can reduce pain. You would receive either the high-CBD product or a placebo (an inactive substance) for one week. The study will measure levels of CBD and its related compounds, as well as markers of inflammation and a natural body chemical called anandamide, to see the product's effects. This study is for women aged 21 and older who have one of these pain conditions and stable medication routines. The current recruitment status is unclear.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor the researchers will know if you're receiving the high-CBD product or placebo. About 60 participants are planned.
What's involved
You would have three visits to McLean Hospital over about one week. These visits include clinical interviews, medical screenings, urine and blood samples, questionnaires, and sensory tests. You would also self-administer the study product and track its use for one week.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at baseline and after 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07728695

Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

Recruiting
PHASE1Ages 21+InterventionalTreatment
Staci Gruber, Ph.D.
~60 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Custom-formulated, high-CBD study productPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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 over Baseline, 7 days
+2 more outcomes measured

Conditions

Endometriosis
Adenomyosis
Chronic Pelvic Inflammatory Disease

Explore related trials

Chronic pelvic inflammatory diseaseEndometriosisUterine Corpus Adenomyosis

NCT07728695

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • McLean Hospital

    Belmont, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Staci Gruber, PhD
[email protected]
617-855-2762
Email the study team

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Eligibility criteria

Inclusion

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
Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)

Exclusion

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

What this trial measures

  • 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)Baseline, 7 days
  • Inflammatory markersBaseline, 7 days
  • Circulating anandamide (AEA)Baseline, 7 days