Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
RecruitingPhase 1, Phase 2NCT07728695
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
- Conditions
- Endometriosis
- Adenomyosis
- Chronic Pelvic Inflammatory Disease
- Interventions
- Drug: Custom-formulated, high-CBD study product
- Drug: Placebo
- Sponsor
- Staci Gruber, Ph.D.
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Organization
- Mclean Hospital
- Start date
- 2026-09
- Primary completion
- 2029-01
- Sex
- Female
- Age range
- from 21 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07728695