Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Staci Gruber, Ph.D.
Study ID
NCT07728695
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Custom-formulated, high-CBD study product — DRUG
    2 doses of the high-CBD study product will be used, compared to placebo.
  • Placebo — DRUG
    Placebo study product.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Rosemary Smith, M.S.
[email protected]
617-855-2908
Staci Gruber, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Belmont, MA

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By condition
Endometriosis
By specialty
Women's healthFertility
By research site
McLean Hospital· Belmont, MA

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