NCT07728695RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Jan 2029
- Lead sponsor
- Staci Gruber, Ph.D.
- Diseases
- Endometriosis
- NCT number
- NCT07728695
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From Sept 2026 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Meets criteria for DSM-5 classification of current substance use disorder, psychotic disorder, bipolar disorder, or an eating disorder
- 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
Lab values
- Liver function test (LFT) values \>3x the upper limit of normal (ULN) at the baseline visit
Other
- Currently uses cannabinoid products
- Positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Disclosure of a genetic polymorphism affecting CYP2C9 function
Who the study is looking for
- 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)
Age in the registry: 21 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.