A Phase 1/2 interventional study of Custom-formulated, high-CBD study product and Placebo in Endometriosis, Adenomyosis and Chronic Pelvic Inflammatory Disease, sponsored by Staci Gruber, Ph.D.. Recruiting at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Staci Gruber, Ph.D. · Phase 1/2, Interventional, and Treatment
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.
This study is a double-blind, placebo-controlled clinical trial of a high-cannabidiol (CBD) sublingual product in individuals with gynecologic pain relating to endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID). The study consists of 3 visits. Participants will be pre-screened by phone to determine initial eligibility, then will come to McLean Hospital for a screening visit. During the screening visit, participants will complete a clinical interview, medical screening, a urine sample, blood draw, and a questionnaire. If approved, participants will come back to the hospital for a baseline visit, and will complete a urine sample, blood draw, questionnaires, and a sensory test. Enrolled participants will be randomized to receive one of two doses of high-CBD study product or placebo, and instructed to self-administer and track their use over the course of one week. Participants will return to the hospital for their final visit consisting of additional urine and blood samples, questionnaires, and sensory testing.
A subset of participants will have the option to complete pharmacokinetic/pharmacodynamic (PK/PD) studies, consisting of additional questionnaires and collection of blood samples through repeated blood draws before and after self-administration of the study product, at the baseline and final study visits. These additional procedures will take up to 8 hours per visit and participants who complete these procedures will receive additional compensation.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Staci Gruber, Ph.D. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for those in the PK subgroup:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will take 1mL of the CBD study product three times per day
Drug: Custom-formulated, high-CBD study product
Participants in this arm will take 0.5mL of the CBD study product three times per day
Drug: Custom-formulated, high-CBD study product
Participants in this arm will take the placebo study product three times per day
Drug: Placebo
2 doses of the high-CBD study product will be used, compared to placebo.
Placebo study product.
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)
Time frame: Baseline, 7 days
Inflammatory markers
Time frame: Baseline, 7 days
Circulating anandamide (AEA)
Time frame: Baseline, 7 days
Plan to share: Undecided — The study group may provide de-identified IPD to other researchers upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2029, 28 months later.
How these figures are worked out, and which studies are left out of them.
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Staci Gruber, Ph.D.