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New treatment option for Endometriosis
Official title Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
ClinicalTrials.gov ID: NCT07728695
What this study is testing
What is Custom-formulated, high-CBD study product?
Custom-formulated, high-CBD study product is an investigational medicine, being studied as a potential treatment for endometriosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only
You may be able to join if
- 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)
You likely can't join if
- 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...
- Comorbid neuropathic pain or cancer-related pain
- Disclosure of a genetic polymorphism affecting CYP2C9 function
See the full eligibility 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 for those in the PK subgroup:
- Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Belmont, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belmont, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.