Recruiting
Phase 1
Phase 2

Hemp-Derived CBD

Sponsor:

Staci Gruber, Ph.D.

Code:

NCT07728695

Conditions

Endometriosis

Adenomyosis

Chronic Pelvic Inflammatory Disease

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Custom-formulated, high-CBD study product

Placebo

Study Details

Brief summary:

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.

Conditions

Endometriosis

Adenomyosis

Chronic Pelvic Inflammatory Disease

Study ID

NCT07728695

Start date

Sep, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBD study product: 1mL dose

Participants in this arm will take 1mL of the CBD study product three times per day

experimental: CBD study product: 0.5mL dose

Participants in this arm will take 0.5mL of the CBD study product three times per day

placebo comparator: Placebo

Participants in this arm will take the placebo study product three times per day

Interventions

Custom-formulated, high-CBD study product

2 doses of the high-CBD study product will be used, compared to placebo.

Placebo

Placebo study product.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Staci Gruber, PhD

617-855-2762gruber@mclean.harvard.edu

Rosie Smith, M.S.

617-855-2908rsmith@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Rosemary Smith, M.S.

617-855-2908rsmith@mclean.harvard.edu

Principal Investigator:

Staci Gruber, PhD

More Information

Sponsor

Staci Gruber, Ph.D.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • cannabidiol
  • gynecologic pain
  • cannabinoid
  • endometriosis
  • adenomyosis
  • pelvic inflammatory disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Staci Gruber, Ph.D. on 2026-07-27.